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90 results on '"Tomcsanyi, Janos"'

1. A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing primary PCI

Author

Adlam, David, Zarebinski, Maciej, Uren, Neal G., Ptaszynski, Pawel, Oldroyd, Keith G., Munir, Shahzad, Zaman, Azfar, Contractor, Hussain, Kiss, Róbert Gábor, Édes, István, Szachniewicz, Joanna, Nagy, Gergely Gyorgy, Garcia, Mario J., Tomcsanyi, János, Irving, John, Sharp, Andrew S.P., Musialek, Piotr, Lupkovics, Géza, Shirodaria, Cheerag, Selvanayagam, Joseph B., Quinn, Pauline, Ng, Leong, Roth, Mark, Insko, Michael A., Haber, Ben, Hill, Stephen, Siegel, Lori, Tulloch, Simon, and Channon, Keith M.

Published
2022
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6. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial

Author

Teerlink, John R, Felker, G Michael, McMurray, John J V, Solomon, Scott D, Adams, Kirkwood F, Jr, Cleland, John G F, Ezekowitz, Justin A, Goudev, Assen, Macdonald, Peter, Metra, Marco, Mitrovic, Veselin, Ponikowski, Piotr, Serpytis, Pranas, Spinar, Jindrich, Tomcsányi, János, Vandekerckhove, Hans J, Voors, Adriaan A, Monsalvo, Maria Laura, Johnston, James, Malik, Fady I, and Honarpour, Narimon

Published
2016
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8. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

Author

Rao, Sunil V., primary, Kirsch, Bodo, additional, Bhatt, Deepak L., additional, Budaj, Andrzej, additional, Coppolecchia, Rosa, additional, Eikelboom, John, additional, James, Stefan K., additional, Jones, W. Schuyler, additional, Merkely, Bela, additional, Keller, Lars, additional, Hermanides, Renicus S., additional, Campo, Gianluca, additional, Ferreiro, José Luis, additional, Shibasaki, Taro, additional, Mundl, Hardi, additional, Alexander, John H., additional, Hengstenberg, Christian, additional, Steinwender, Clemens, additional, Alber, Hannes, additional, Steringer-Mascherbauer, Regina, additional, Schober, Andreas, additional, Auer, Johann, additional, Roithinger, Franz Xaver, additional, von Lewinski, Dirk, additional, Moertl, Deddo, additional, Huber, Kurt, additional, Coussement, Patrick, additional, Hoffer, Etienne, additional, Beauloye, Christophe, additional, Janssens, Luc, additional, Vranckx, Pascal, additional, De Raedt, Herbert, additional, Vanassche, Thomas, additional, Vrolix, Matthias, additional, Rokyta, Richard, additional, Parenica, Jiri, additional, Pelouch, Radek, additional, Motovska, Zuzanna, additional, Alan, David, additional, Kettner, Jiri, additional, Polasek, Rostislav, additional, Cermak, Ondrej, additional, Sedlon, Pavel, additional, Hanis, Jiri, additional, Novak, Martin, additional, Belohlavek, Jan, additional, Horacek, Thomas, additional, Leggewie, Stefan, additional, Wenzel, Philip, additional, vom Dahl, Juergen, additional, Sievers, Burkhard, additional, Pulz, Jan, additional, Schellong, Sebastian, additional, Clemmensen, Peter, additional, Muller-Hennessen, Matthias, additional, Rassaf, Tienush, additional, Falukozi, Jozsef, additional, Ruzsa, Zoltan, additional, Tomcsanyi, Janos, additional, Csanadi, Zoltan, additional, Herczeg, Bela, additional, Koszegi, Zsolt, additional, Vorobcsuk, Andras, additional, Kiss, Robert, additional, Baranyai, Csaba, additional, Dezsi, Csaba, additional, Lupkovics, Geza, additional, Rossini, Roberta, additional, Scherillo, Marino, additional, Sergio Saba, Pier, additional, Calogero Campo, Gianluca, additional, Calo, Leonardo, additional, Nassiacos, Daniele, additional, Quadri, Giorgio, additional, Sciahbasi, Alessandro, additional, Silvio Marenzi, Gian Carlo, additional, Reimers, Bernhard, additional, Perna, Gian Piero, additional, Sacca, Salvatore, additional, Fattore, Luciano, additional, Brunelli, Claudio, additional, Picchi, Andrea, additional, Kuramochi, Takehiko, additional, Kondo, Kazuhisa, additional, Aoyama, Takahiko, additional, Kudoh, Takashi, additional, Yamamoto, Tadashi, additional, Takaya, Tomofumi, additional, Mukai, Yasushi, additional, Fukui, Kazuki, additional, Morioka, Nobuyuki, additional, Ando, Kenji, additional, Yamamuro, Atsushi, additional, Morita, Yasuhiro, additional, Koga, Yasuaki, additional, Watanabe, Tetsuya, additional, Sakamoto, Tomohiro, additional, Maebuchi, Daisuke, additional, Takahashi, Akihiko, additional, Yonetsu, Taishi, additional, Kakuta, Tsunekazu, additional, Nishina, Hidetaka, additional, Oemrawsingh, Rohit, additional, Dorman, Reinhart, additional, Oude Ophius, Ton, additional, Prins, Paco, additional, al Windy, N.Y.Y., additional, Zoet-Nugteren, S.K., additional, Hermanides, Rik, additional, van Eck, Martijn, additional, Scherptong, Roderick, additional, Cornel, J.H., additional, Damman, Peter, additional, Bech, Gerhard, additional, Torquay, R., additional, Kietselaer, Bas, additional, Grzelakowski, Pawel, additional, Krzysztof, Dyrbus, additional, Miekus, Pawel, additional, Przybylski, Andrzej, additional, Zarebinski, Maciej, additional, Balsam, Pawel, additional, Szachniewicz, Joanna, additional, Gierlotka, Marek, additional, Tycinska, Agnieszka, additional, Iniguez Romo, Andres, additional, Fernandez Ortiz, Antonio, additional, Carrasquer Cucarella, Anna, additional, Sanmartin Fernandez, Marcelo, additional, Sionis, Alessandro, additional, Bueno Zamora, Hector, additional, Ferreiro Gutierrez, Jose Luis, additional, Almenar, Luis, additional, Ferreira Gonzalez, Ignacio, additional, Pascual Figal, Domingo A., additional, Almendro Delia, Manuel, additional, Jimenez Fernandez, Miriam, additional, Skeppholm, Mika, additional, Zedigh, Crister, additional, Angeras, Oskar, additional, Lauermann, Jorg, additional, Erlinge, David, additional, Gustafsson, Robin, additional, Mooe, Thomas, additional, Utreras, Alejandro, additional, James, Stefan, additional, Grimfjard, Per, additional, Pedrazzini, Giovanni, additional, Mach, Francois, additional, Fournier, Stephane, additional, Haegeli, Laurent, additional, Beer, Jurg H., additional, Leibundgut, Gregor, additional, Kobza, Richard, additional, Kaiser, Christoph, additional, Kunadian, Vijay, additional, Al-Lamee, Rasha, additional, Gorog, Diana, additional, Khan, Sohail, additional, Trevelyan, Jasper, additional, Toor, Iqbal, additional, Smith, James, additional, Purushottam, Bhaskar, additional, Treasure, Charles, additional, Arena, Frank, additional, Vedere, Amarnath, additional, Henderson, David, additional, Gilani, Syed, additional, Jones, Alonzo, additional, Carrillo-Jimenez, Rodolfo, additional, Gillespie, Eve, additional, Marhefka, Gregary, additional, Wang, David, additional, Olson, Charles, additional, Bloom, Stephen, additional, Iftikhar, Faizan, additional, Brabham, David, additional, McGinty, John, additional, Thompson, Charles, additional, Talano, James, additional, Ginete, Wilson, additional, Williams, Marcus, additional, Masud, Ali, additional, Ariani, Mehrdad, additional, Bitar, Fahed, additional, Wang, Thomas, additional, and Samuelson, Bradley, additional

Published
2022
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11. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial

Author

Felker, G. Michael, Solomon, Scott D., Claggett, Brian, Diaz, Rafael, McMurray, John J. V, Metra, Marco, Anand, Inder, Crespo-Leiro, Marisa G., Dahlström, Ulf, Goncalvesova, Eva, Howlett, Jonathan G., MacDonald, Peter, Parkhomenko, Alexander, Tomcsanyi, Janos, Abbasi, Siddique A., Heitner, Stephen B., Hucko, Thomas, Kupfer, Stuart, Malik, Fady I, Teerlink, John R., Felker, G. Michael, Solomon, Scott D., Claggett, Brian, Diaz, Rafael, McMurray, John J. V, Metra, Marco, Anand, Inder, Crespo-Leiro, Marisa G., Dahlström, Ulf, Goncalvesova, Eva, Howlett, Jonathan G., MacDonald, Peter, Parkhomenko, Alexander, Tomcsanyi, Janos, Abbasi, Siddique A., Heitner, Stephen B., Hucko, Thomas, Kupfer, Stuart, Malik, Fady I, and Teerlink, John R.

Abstract

IMPORTANCE Heart failure with reduced ejection fraction is a progressive clinical syndrome, and many patients condition worsen over time despite treatment. Patients with more severe disease are often intolerant of available medical therapies. OBJECTIVE To evaluate the efficacy and safety of omecamtiv mecarbil for the treatment of patients with severe heart failure (HF) enrolled in the Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTS The GALACTIC-HF study was a global double-blind, placebo-controlled phase 3 randomized clinical trial that was conducted at multiple centers between January 2017 and August 2020. A total of 8232 patients with symptomatic HF (defined as New York Heart Association symptom class II-IV) and left ventricular ejection fraction of 35% or less were randomized to receive omecamtiv mecarbil or placebo and followed up for a median of 21.8 months (range, 15.4-28.6 months). The current post hoc analysis evaluated the efficacy and safety of omecamtiv mecarbil therapy among patients classified as having severe HF compared with patients without severe HF. Severe HF was defined as the presence of all of the following criteria: New York Heart Association symptom class III to IV, left ventricular ejection fraction of 30% or less, and hospitalization for HF within the previous 6 months. INTERVENTIONS Participants were randomized at a 1:1 ratio to receive either omecamtiv mecarbil or placebo. MAIN OUTCOMES AND MEASURES The primary end point was time to first HF event or cardiovascular (CV) death. Secondary end points included time to CV death and safety and tolerability. RESULTS Among 8232 patients enrolled in the GALACTIC-HF clinical trial, 2258 patients (27.4%; mean [SD] age, 64.5 [11.6] years; 1781 men [78.9%]) met the specified criteria for severe HF. Of those, 1106 patients were randomized to the omecamtiv mecarbil group and 11, Funding Agencies|AmgenAmgen; Cytokinetics; Servier Laboratories

Published
2022
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13. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

Author

Montalescot, Gilles, Pitt, Bertram, Lopez de Sa, Esteban, Hamm, Christian W., Flather, Marcus, Verheugt, Freek, Shi, Harry, Turgonyi, Eva, Orri, Miguel, Vincent, John, Zannad, Faiez, Noll, Georg, Weir, Robin, OʼNeill, Blair, Böhm, Michael, Hillis, W. Stuart, Grieve, Andrew, Rouleau, Jean-Lucien, Gerasimos, Filippatos, Fitchett, David, Lepage, Serge, Madan, Minakshi, Sussex, Bruce, Tremblay, Gerald, Welsh, Robert, Wong, Graham, Hutyra, Martin, Kettner, Jiri, Ostadal, Petr, Spinar, Jindrich, Vojacek, Jan, Barboteu, Michel, Collet, Jean-Philippe, Coste, Pierre, Cottin, Yves, Ducos, Dominique, Galinier, Michel, Teiger, Emmanuel, Zemour, Gilles, Bauersachs, Johann, Hambrecht, Rainer, Hauf, Gerhard, Heuer, Hubertus, Mudra, Harald, Münzel, Thomas, Steiner, Stephan, Strasser, Ruth, Sydow, Karsten, Tschöpe, Carsten, Wachter, Rolf, Werner, Nikos, Alexopoulos, Dimitros, Babalis, Dimitrios, Pyrgakis, Vlassios, Dezsi, Csaba, Lupkovics, Geza, Polgar, Peter, Tomcsanyi, Janos, Herrman, J., ten Berg, J.M., Gorny, Jerzy, Kubica, Jacek, Lewczuk, Jerzy, Zmuda, Witold, Hranai, Marian, Kovar, Frantisek, Margoczy, Roman, Micko, Karol, Sumbal, Jaroslav, Genover, Xavier Bosch, Ortiz, Antonio Fernandez, Sala, Miguel Fiol, Garcia, Cosme Garcia, Muñoz, Carlos Perez, Rey Blas, Juan Ramon, Soriano, Franciso Ridocci, Adamson, Dawn, Alamgir, Farqad, Chauhan, Anoop, Lip, Gregory, Martin, Thomas, McCann, Gerry, Newby, David, and Smith, David

Published
2014
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15. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Author

Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo‐Leiro, Maria G., Dahlström, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cândida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., Kurtz, Christopher E., Besada, Diego Alejandro, Majul, Claudio Rodolfo, Bruno, Marco Raul Litvak, Sassone, Sonia, Avaca, Horacio Alberto, Rasmussen, Mariela, Aiub, Jorge Roberto, Hominal, Miguel Angel, Perna, Eduardo, Duran, Ruben Omar Garcia, Schiavi, Lilia, Marquez, Lilia Luz Lobo, Vilamajo, Oscar Alberto Gomez, Mackinnon, Ignacio, Fuente, Ricardo Alfonso Leon, Montana, Oscar Romano, Novaretto, Leonardo, Guerrero, Rodolfo Andres Ahuad, Brasca, Daniela Garcia, Prado, Aldo, Garrido, Marcelo Alejandro, Luquez, Hugo, Martinez, Diego Felipe, Nicolosi, Liliana, Parody, Maria Leonor, Zaidman, Cesar, Berra, Fernando Colombo, Ibañez, Julio, Zapata, Gerardo, Caccavo, Alberto, Colque, Roberto, Diez, Mirta, Poy, Carlos, Salomone, Oscar Alejandro, Vogel, Daniel, Bordonava, Anselmo Paulino, Fernandez, Alberto, French, John, Atherton, John, Hamilton, Andrew, Begg, Alistair, Abhayaratna, Walter, Judkins, Christopher, De Pasquale, Carmine, McKenzie, Scott, Amerena, John, Szto, Gregory, Kearney, Leighton, Zimmet, Hendrik, Sverdlov, Aaron, Beltrame, John, Korczyk, Dariusz, Sindone, Andrew, Moertl, Deddo, Huber, Kurt, Huelsmann, Martin, Ablasser, Klemens, Ebner, Christian, Siostrzonek, Peter, Drexel, Heinz, Poelzl, Gerhard, Dujardin, Karl, Dupont, Matthias, Buysschaert, Ian, Lancellotti, Patrizio, Droogne, Walter, Chouchane, Iman, Silveira, Fabio, Rassi, Salvador, Reis, Gilmar, Filho, Pedro Pimentel, Simoes, Marcus Vinicius, Braga, Joao Carlos, Giorgeto, Flavio Eduardo, Ferraz, Almir, Jaeger, Cristiano Pederneiras, Saraiva, Jose Francisco, Tognon, Alexandre, Cardoso, Juliano, Greco, Oswaldo, Paiva, Maria Sanali, Paolino, Bruno, Filho, Otavio Coelho, Maia, Lilia Nigro, Silva, Rodrigo, Canesin, Manoel, Rossi, Paulo Roberto Ferreira, Fortes, Jose Augusto Ribas, Cerci, Rodrigo Julio, Manenti, Euler Roberto Fernandes, Leaes, Paulo Ernesto, Silva Neto, Luis Beck, Souza, Weimar Kunz Barroso, Bacal, Fernando, Chaves, Renato, Ramires, Felix, Vidotti, Maria Helena, Barros e Silva, Pedro Gabriel Melo, Piegas, Leopoldo Soares, Todorov, Georgi, Tzekova, Maria, Goudev, Assen, Mincheva, Valentina, Vasilev, Ivaylo, Tisheva‐ Gospodinova, Snezhanka, Petrov, Ivo, Postadzhiyan, Arman, Velikov, Chavdar, Dimov, Bojidar, Constance, Christian, Phaneuf, Denis‐Carl, Mielniczuk, Lisa, Pandey, A Shekhar, Senaratne, Manohara, Zieroth, Shelley, Savard, Daniel, Stewart, Robert, Huynh, Thao, Giannetti, Nadia, Moe, Gordon, Bourgeois, Ronald, Ezekowitz, Justin, Hartleib, Michael, Sussex, Bruce, Babapulle, Mohan, Chehayeb, Raja, Gaudet, Daniel, McKelvie, Robert, Nguyen, Viviane, Roth, Sherryn, Gupta, Milan, Pesant, Yves, Rupka, Dennis, Bhargava, Rakesh, Costa‐Vitali, Atilio, Proulx, Guy, Vega, Mario, Potthoff, Sergio, Cid, Maria Cristina Schnettler, Sepulveda, Alex Mauricio Villablanca, Zanetti, Fernando Tomas Lanas, Gajardo, Victor Areli Saavedra, Kindel, Carlos Conejeros, Jofre, Christian Paolo Pincetti, Segarra, Jorge Leonardo Cobos, Venegas, Manuel Eduardo Rodriguez, Hidalgo, Mario Yanez, Jalaf, Margarita Gertrudis Vejar, Li, Weimin, Zhang, Jinguo, Fu, Xin, Zhang, Xuelian, Li, Dongye, Wang, Zhifang, Qu, Yanling, Zheng, Zhe, Tang, Huifang, Yang, Ping, Zhang, Yuhui, Zheng, Yang, Mi, Yafei, Huang, He, Bu, Peili, Chen, Guoqin, Chen, Jiyan, Han, Yajun, Li, Zhangquan, Ma, Shumei, Yang, Xuming, Yuan, Zuyi, Dong, Yugang, Li, Zhaoping, Mahemuti, Ailiman, Niu, Wentang, Yang, Zhenyu, Zhang, Yuqing, Sun, Yuemin, Wu, Weiheng, Liu, Feng, Yan, Jing, Li, Yinjun, Wang, Yi, Zhang, Shouyan, Zhou, Changyong, Cui, Hanbin, Li, Jianjun, Li, Tianfa, Han, Qinghua, Wei, Yu, Correa, Luis Eduardo Echeverria, Mendoza, Jose Luis Accini, Jattin, Fernando Manzur, Osorio, Wilder Castaño, Luengas, Carlos Alberto, Arroyo, Julian Alonso Coronel, Corredor, Miguel Alfredo Moncada, Giraldo, Clara Ines Saldarriaga, Lopez, Rodrigo Botero, Salazar, Dora Ines Molina, Triana, Miguel Urina, Lopez, Luis Horacio Atehortua, Rojas, Pastor Olaya, Pelaez, Sebastian Velez, Pareja, Monica Lopez, Bonfanti, Alberto Cadena, Polasek, Rostislav, Monhart, Zdenek, Sochor, Karel, Motovska, Zuzana, Belohlavek, Jan, Busak, Ladislav, Krupicka, Jiri, Tyl, Petr, Jerabek, Ondrej, Podpera, Ivo, Skrobakova, Janka, Peterka, Karel, Spacek, Rudolf, Cech, Vladimir, Kellnerova, Ivana, Nechvatal, Libor, Pozdisek, Zbynek, Houra, Marek, Kryza, Radim, Machova, Vilma, Cepelak, Michal, Stepek, David, Zeman, Kamil, Klimsa, Zdenek, Koleckar, Pavel, Schee, Alexandr, Spinarova, Lenka, Coufal, Zdenek, Jeppesen, Jorgen, Vraa, Soren, Wiggers, Henrik, Nyvad, Ole, Nielsen, Tonny, Kaiser‐Nielsen, Peter, Videbaek, Lars, Galinier, Michel, Lefebvre, Jean‐Marie, Tartiere, Jean‐Michel, De Geeter, Guillaume, Roubille, Francois, Ricci, Jean Etienne, Salvat, Muriel, Gueffet, Jean‐Pierre, Decoulx, Eric, Berdague, Philippe, Jondeau, Guillaume, Ovize, Michel, Groote, Pascal De, Donal, Erwan, Isnard, Richard, Sabatier, Rémi, Trochu, Jean Noel, Damy, Thibaud, Georges, Jean‐Louis, Rosamel, Yann, Picard, François, Aboyans, Victor, Laperche, Thierry, Mitrovic, Veselin, Taggeselle, Jens, Störk, Stefan, Ebelt, Henning, Genth‐Zotz, Sabine, Rassaf, Tienush, Duengen, Hans‐Dirk, Mittag, Marcus, Menck, Niels, Zeymer, Uwe, Haehling, Stephan, Boehm, Michael, Frankenstein, Lutz, Killat, Holger, Bourhaial, Hakima, Beug, Daniel, Horacek, Thomas, Pfister, Roman, Sandri, Marcus, Westenfeld, Ralf, Kadel, Christoph, Karvounis, Haralambos, Patsilinakos, Sotirios, Mantas, Ioannis, Karavidas, Apostolos, Giamouzis, Grigorios, Tsioufis, Konstantinos, Naka, Katerina, Tziakas, Dimitrios, Parissis, John, Styliadis, Ioannis, Barbetseas, Ioannis, Manolis, Athanasios, Kochiadakis, George, Herczeg, Bela, Nagy, Laszlo, Nyolczas, Noemi, Toth, Kalman, Merkely, Bela, Laszlo, Zoltan, Mark, Laszlo, Szakal, Imre, Papp, Andras, Bezzegh, Katalin, Lakatos, Ferenc, Hajko, Erik, Papp, Aniko, Forster, Tamas, Lupkovics, Geza, Mohacsi, Attila, Salamon, Csaba, Aradi, Daniel, Andreka, Peter, Szasz, Gyula, Zilahi, Zsolt, Kazinczy, Rita, Margonato, Alberto, Agostoni, Piergiuseppe, Fucili, Alessandro, Piovaccari, Giancarlo, Senni, Michele, Carluccio, Erberto, Bilato, Claudio, Frigerio, Maria, Indolfi, Ciro, Sinagra, Gianfranco, Brunetti, Natale Daniele, Perna, Gianpiero, Pini, Daniela, Volterrani, Maurizio, Leonardi, Sergio, Mortara, Andrea, Friz, Hernan Emilio Francisco Polo, Rossini, Roberta, Tocchetti, Carlo Gabriele, Vincenzi, Antonella, Cavallini, Claudio, Floresta, Agata Marina, Zaca, Valerio, Giudici, Vittorio, Villani, Giovanni Quinto, Higashino, Yorihiko, Oishi, Shogo, Wada, Atsuyuki, Fukuzawa, Shigeru, Onoue, Kenji, Koike, Akihiro, Koizumi, Tomomi, Masuda, Seigo, Mitsuo, Kazuhisa, Takahashi, Natsuki, Takenaka, Takashi, Tanabe, Jun, Watanabe, Naoki, Yoshida, Takeshi, Amano, Tetsuya, Ishikawa, Masahiro, Kida, Keisuke, Kubota, Toru, Nakamura, Kentaro, Sakamoto, Tomohiro, Shimomura, Mitsuhiro, Yuge, Masaru, Doi, Masayuki, Domae, Hiroshi, Ebato, Mio, Fujii, Kenshi, Fujiwara, Wakaya, Gohara, Seiichiro, Hata, Yoshiki, Kanda, Junji, Kitaoka, Hiroaki, Matsumoto, Takashi, Michishita, Ichiro, Miura, Shinichiro, Miyazaki, Tetsuro, Nakamura, Akihiro, Ogawa, Tomohiro, Okumura, Takahiro, Okumura, Yasuo, Sakai, Tetsuo, Sato, Yukihito, Shimizu, Wataru, Sugino, Hiroshi, Suzuki, Masahiro, Takagi, Atsutoshi, Takaishi, Hiroshi, Tanaka, Takahiro, Terasaki, Toshiro, Tsujimoto, Mitsuru, Ueda, Yasunori, Ujino, Keiji, Usui, Makoto, Yamamoto, Mitsutaka, Yoshikawa, Masaki, Ando, Kenji, Asakura, Masanori, Asano, Hiroshi, Fujii, Shigeru, Hara, Hisao, Inomata, Takayuki, Isshiki, Takaaki, Kadokami, Toshiaki, Kai, Hisashi, Kasai, Toshio, Kawamitsu, Katsunori, Kawasaki, Tomohiro, Koga, Tokushi, Komiyama, Nobuyuki, Maejima, Yasuhiro, Manita, Mamoru, Miyamoto, Nobuhide, Node, Koichi, Numaguchi, Kotaro, Sakata, Yasushi, Serikawa, Takeshi, Takama, Noriaki, Tatebe, Shunsuke, Ueno, Hideki, Hidaka, Takayuki, Hiroi, Shitoshi, Iseki, Harukazu, Ito, Hiroshi, Kajinami, Kouji, Kawakami, Hideo, Momiyama, Yukihiko, Mori, Masuki, Morita, Yukiko, Okishige, Kaoru, Sakagami, Satoru, Takeishi, Yasuchika, Terasawa, Akihiro, Utsu, Noriaki, Badariene, Jolita, Celutkiene, Jelena, Slapikas, Rimvydas, Jarasuniene, Dalia, Castillo, Armando Garcia, De los Rios Ibarra, Manuel Odin, Lopez, Gabriel Arturo Ramos, Llamas, Edmundo Alfredo Bayram, Esperon, Guillermo Antonio Llamas, Vazquez, Eduardo Salcido, Gonzalez, Ricardo Garcia, Leon, Jose Luis Arenas, Gonzalez, Salvador Leon, Mendoza, Maria Alexandra Arias, Rodriguez, Alicia Contreras, Machado, Gustavo Francisco Mendez, Salazar, Melchor Alpizar, Ruiz, Alberto Esteban Bazzoni, Flores, Ana Maria De Leon, Carrasco, Jose Alfredo Pagola, Araiza, Raul Reyes, Römer, Tjeerd, Remmen, Johannes, Van Eck, Jacob, Elvan, Arif, Smilde, Tom, Voors, Adriaan, Wal, Ruud, Schaap, Jeroen, Sluis, Aize, Linssen, Gerardus, Magro, Michael, Willems, Frank, Hal, John, Zwaan, Coenraad, Beelen, Driek, Boswijk, Dirk, Hermans, Walter, Van Kesteren, Henricus, Scott, Russell, Hart, Hamish, Lund, Marianne, Szczasny, Marcin, Blicharski, Tomasz, Kafara, Mariusz, Stankiewicz, Anna, Skonieczny, Grzegorz, Zabowka, Maciej, Kania, Grzegorz, Kopaczewski, Jerzy, Pawlowicz, Lidia, Spyra, Janusz, Wlodarczyk, Aleksander, Sciborski, Ryszard, Balsam, Pawel, Drozdz, Jaroslaw, Sobkowicz, Bozena, Konieczynska, Malgorzata, Lelonek, Malgorzata, Bednarkiewicz, Zbigniew, Trebacz, Jaroslaw, Jankowski, Piotr, Sidor, Mateusz, Berkowski, Piotr, Chmielak, Zbigniew, Lenartowska, Lucyna, Nessler, Jadwiga, Straburzynska‐Migaj, Ewa, Kalarus, Zbigniew, Kowalski, Robert, Kalecinska‐Krystkiewicz, Ewa, Gola, Zbigniew, Pijanowski, Zbigniew, Wozakowska‐Kaplon, Beata, Cymerman, Krzysztof, Rynkiewicz, Andrzej, Miekus, Pawel, Monteiro, Pedro, Sarmento, Pedro Morais, Almeida, Filipa, Duarte, Tatiana, Fonseca, Candida, Oliveira, Luis, Santos, Luis, Brito, Dulce, Stanciulescu, Gabriela, Spiridon, Marilena Renata, Militaru, Constantin, Podoleanu, Cristian Gheorghe, Zdrenghea, Dumitru, Popescu, Mircea Ioachim, Macarie, Cezar‐Eugen, Giuca, Alina, Mitu, Florin, Voicu, Olga‐Cristina, Dorobantu, Maria, Lighezan, Daniel, Stamate, Sorin, Bykov, Alexander, Kobalava, Zhanna, Zrazhevskiy, Konstantin, Semenova, Irina, Vishnevsky, Alexander, Shutemova, Elena, Tereschenko, Sergey, Shvarts, Yury, Barbarash, Olga, Lukyanov, Yury, Voevoda, Mikhail, Dovgolis, Svetlana, Dronov, Dmitry, Goloshchekin, Boris, Sitnikova, Maria, Ezhov, Marat, Tarasov, Nikolay, Kotelnikov, Mikhail, Kostenko, Viktor, Solovev, Oleg, Goncharov, Ivan, Myasnikov, Roman, Rafalskiy, Vladimir, Ryabov, Vyacheslav, Kosmacheva, Elena, Motylev, Igor, Nosov, Vladimir, Osipova, Irina, Salukhov, Vladimir, Belenkiy, Dmitriy, Bolshakova, Olga, Pimenov, Leonid, Shilkina, Nataliya, Kulibaba, Elena, Repin, Alexey, Timofeev, Alexander, Mitrokhin, Vladislav, Sherenkov, Alexander, Arbolishvili, Georgy, Antalik, Lubomir, Dzupina, Andrej, Fulop, Peter, Majercak, Ivan, Gonsorcik, Jozef, Vinanska, Daniela, Lenner, Egon, Lukacova, Jana, Margoczy, Roman, Smik, Rudolf, Stevlik, Jan, Uhliar, Rudolf, Burgess, Lesley, Badat, Aysha, Klug, Eric, Van Zyl, Louis, Abelson, Mark, Moodley, Rajendran, Tsabedze, Nqoba, Fourie, Nyda, Bonet, Luis Almenar, Prado, Jose Maria Arizon, Oliveira Soares, Manue Martinez‐Selles D, Villota, Julio Eduardo Nuñez, Leiro, Maria Generosa Crespo, Juanatey, Jose Ramon Gonzalez, Figal, Domingo Andres Pascual, Palomas, Juan Luis Bonilla, Perez, Sonia Mirabet, Jimenez, Juan Francisco Delgado, Padron, Antonio Lara, Diaz, Victor Alfonso Jimenez, Cubero, Javier Segovia, Paya, Vicente Eduardo Climent, Mayoral, Alejandro Recio, Fuente Galan, Luis, Doblas, Juan Jose Gomez, Freire, Ramon Bover, Peiro, Maria Teresa Blasco, Molina, Beatriz Diaz, Martinez, Laura Jordan, Vilchez, Francisco Gonzalez, Boman, Kurt, Karlstrom, Patric, Berglund, Stefan, Szabo, Barna, Peterson, Magnus, Wodlin, Peter, Lindholm, Carl‐Johan, Moccetti, Tiziano, Mueller, Christian, Suter, Thomas, Hullin, Roger, Meyer, Philippe, Noll, Georg, Yigit, Zerrin, Turgut, Okan Onur, Bekar, Lutfu, Sahin, Tayfun, Koldas, Zehra Lale, Celik, Ahmet, Cavusoglu, Yuksel, Demir, Mesut, Onrat, Ersel, Duzenli, Mehmet, Cosansu, Kahraman, Muderrisoglu, Ibrahim Haldun, Tuncer, Mustafa, Badak, Ozer, Nalbantgil, Sanem, Kirma, Cevat, Okuyan, Ertugrul, Guray, Umit, Prokhorov, Oleksandr, Karpenko, Oleksandr, Vakaliuk, Igor, Yagensky, Andriy, Kracz, Igor, Stanislavchuk, Mykola, Kulynych, Oleksii, Rishko, Mykola, Stets, Roman, Tseluyko, Vira, Mishchenko, Larysa, Rudenko, Leonid, Rudyk, Iurii, Alieksieieva, Liudmyla, Korzh, Oleksii, Mostovoy, Yuriy, Parkhomenko, Oleksandr, Rasputina, Lesya, Voronkov, Leonid, Lymar, Yurii, Vasilyeva, Larysa, Keeling, Philip, Barr, Craig, Wong, Kenneth, Price, Dallas, Skaria, Binoy, Clark, Andrew, Chandrasekaran, Badrinathan, Trevelyan, Jasper, Gordon, Brian, Donnelly, Patrick, Glover, Jason, Ryding, Alisdair, Weir, Robin, Lang, Chim, Roy, Debashis, Adhya, Shaumik, Clifford, Piers, Ludman, Andrew, Kalra, Paul, Lynch, Mary, Mahmood, Shahid, Al Mohammad, Abdallah, Asubiaro, Joshua, Elmahi, Einas, Muthumala, Amal, Taylor, Justin, Gupta, Dinesh, Nadar, Venkatesh, Henderson, David, Zolty, Ronald, Sauer, Andrew, Adams, Kirkwood, Chandra, Lokesh, Jaffrani, Naseem, Grewal, Gurinder, Mancini, Donna, McLean, Dalton, Vasallo, Javier, Gottlieb, Stephen, Joseph, Susan, Barua, Rajat, Gorodeski, Eiran, Mouhaffel, Asad, Chung, Eugene, Desai, Pratik, Portnay, Edward, Rama, Bhola, Shandling, Adrian, Stahl, Llyod, Heilman, Karl, Jacob, Binu, Londono, Juan, Almousalli, Omar, Ashcom, Thomas, Bauerlein, Eugene Joseph, Koo, Charles, McGrew, Frank, Rajagopalan, Navin, Robinson, Shawn, Schultz, David, Starling, Randall, Ambardekar, Amrut, Bhagwat, Ravi, Boehmer, John, Bouza, Manuel, Farris, Neil, Feitell, Scott, Ganji, Jagadeesh, Geltman, Edward, Javier, Julian, Morrow, John Andrew, Pianko, Leonard, Smart, Frank, Adler, Alexander, Brinkley, Douglas, Cardona, Jose, Coletti, Andrew, Harris, John, Hunter, Vernon, Krantz, Mori, Lang, Christopher, Lovell, Charles, Murray, David, Pillutla, Priya, Shah, Amit, Bogaev, Roberta, Dauber, Ira, Franchi, Francesco, Fremont, Richard, Hart, Terence, Hattler, Brack, Janik, Matthew, Khalife, Wissam, Malhotra, Sanjay, Mamdani, Shafiq, Nelson, William, Orgera, Marisa, Ortiz, Aurelio, Rahko, Peter, Rennyson, Stephen, Shin, Jooyoung, Tsao, Lana, Uretsky, Barry, Wahid, Faisal, Wilkett, Matt, Amanullah, Aman, Baker, Mathue, Berk, Martin, Boccalandro, Fernando, Cruz, Kimberly, Doyle, Timothy, Gianfagna, Robert, Jones, Alonzo, King, Anthony, Lepor, Norman, Martinez‐Castrillon, Melvin, Pham, Michael, Radin, Michael, Radojevic, Joseph, Ramanathan, Kodangudi, Schmalfuss, Carsten, Schnitzler, Robert, Shah, Keyur, Takata, Theodore, Bertolet, Barry, Bostick, Brian, Civitello, Andrew, Collins, John, Dib, Nabil, Fang, James, Gilmore, Richard, Gray, Wayne, Grazette, Luanda, Haddad, Tariq, Hearne, Steven, Janmohamed, Munir, Katz, Richard, Kazemi, Navid, Llerena, Sara, Lohr, Nicole, Marzouka, George, Mignone, John, Ooi, Henry, Paszczuk, Anna, Pickett, Christopher, Sampognaro, Gregory, Sawyer, Douglas, Shayani, Steven, Treasure, Charles, Vaz, Garth, Vijay, Nampalli, Williams, Celeste, Yeoman, Gary, Zhang, Lily, Aaronson, Keith, Abo‐Auda, Wael, Alharethi, Rami, Anderson, William, Ariani, Mehrdad, Banerji, Sourin, Baweja, Paramdeep, Carson, Peter, Eberly, Arthur, Elliott, James, Fernando, Ronald, Fisher, Daniel, Forman, Steven, Gabriel, George, Gogia, Harinder, Hametz, Craig, Houston, Brian, Ibrahim, Hassan, Jadbabaie, Farid, Kassiotis, Christos, Krishnamoorthy, Arun, Kwan, Michael, Lupovitch, Steven, Macias, Leonardo, Malik, Adnan, Martinez, Luis, Miyamoto, Michael, Mody, Freny, Patel, Devesh, Peart, Brenda, Pisani, Barbara, Ramos, Mark, Rivero, Mariel, Shah, Anil, Sharma, Mukesh, Sichrovsky, Tina, Simon, Marc, Singh, Deovrat, Tallet, Julio, Vaccari, Christopher, Villoch, Mario, Wheeler, Matthew, Yousuf, Kabir, Abadier, Rafik, Abdullah, Shuaib, Arora, Raveen, Aslam, Shamaila, Buynak, Robert, Chang, David, Contreras, Johanna, Halpern, Stephen, Handel, Franklin, Heitner, John, Herzog, William, Jackson, Bruce, Kao, John, Kondo, Nicholas, Koren, Michael, LeWinter, Martin, Martindale, Jeffrey, Martinez‐Arraras, Joaquin, Olsen, Stephanie, Piatek, Marek, Ranadive, Nandkishore, Randall, William, Rao, Sunder, Rawitscher, David, Rider, James, Sokos, George, Strader, J Russell, Sulemanjee, Nasir, Tahirkheli, Naeem, Trichon, Benjamin, Vanhecke, Thomas, Whellan, David, Abuannadi, Mohammad, Aggarwala, Gaurav, Ahmad, Saad, Artis, Andre, Cheirif, Jorge, Cotarlan, Vladimir, Cox, Jeremy, Eaton, Charles, Florea, Viorel, Frank, Theodore, Friedman, Keith, Ganeshram, Vedampattu, Gass, Alan, Gemignani, Anthony, Hasni, Syed, Hedgepeth, Chester, Itchhaporia, Dipti, Kaluski, Edo, Karim, Amin, Kono, Alan, Lader, Ellis, Lakshminarayanan, Batlagundu, Lewis, Neil, Malhotra, Vinay, Mayer, Nolan, Mohapatra, Robert, Nair, Nandini, O'Brien, Terrence, Pauwaa, Sunil, Rowan, Christopher, Saxena, Sanjeev, Seto, Arnold, Shah, Nishant, Singh, Pradeep, Skopicki, Hal, Stoddard, Marcus, and Sweitzer, Nancy

Subjects
R1
Abstract

Aims:\ud The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.\ud \ud Methods and Results:\ud Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure

Published
2020

16. Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure

Author

Teerlink, John R., Diaz, Rafael, Michael Felker, G., McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias-Mendoza, Alexandra, Biering-Sorensen, Tor, Bohm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo-Leiro, Maria G., Dahlstrom, Ulf, Echeverria, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Candida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Li, Jing, Lund, Mayanna, Macdonald, Peter, Mareev, Viacheslav, Momomura, Shin'ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J.A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Varin, Claire, Honarpour, Narimon, Abbasi, Siddique A., Malik, Fady I., Kurtz, Christopher E., Teerlink, John R., Diaz, Rafael, Michael Felker, G., McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias-Mendoza, Alexandra, Biering-Sorensen, Tor, Bohm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo-Leiro, Maria G., Dahlstrom, Ulf, Echeverria, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Candida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Li, Jing, Lund, Mayanna, Macdonald, Peter, Mareev, Viacheslav, Momomura, Shin'ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J.A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Varin, Claire, Honarpour, Narimon, Abbasi, Siddique A., Malik, Fady I., and Kurtz, Christopher E.

Abstract

BACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.).

Published
2021

18. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

Author

Maggioni, Aldo P., Greene, Stephen J., Fonarow, Gregg C., Böhm, Michael, Zannad, Faiez, Solomon, Scott D., Lewis, Eldrin F., Baschiera, Fabio, Hua, Tsushung A., Gimpelewicz, Claudio R., Lesogor, Anastasia, Gheorghiade, Mihai, Ramos, Silvina, Luna, Alejandra, Miriuka, Santiago, Diez, Mirta, Perna, Eduardo, Luquez, Hugo, Pinna, Jorge Garcia, Castagnino, Jorge, Alvarenga, Pablo, Ibañez, Julio, Blumberg, Eduardo Salmon, Dizeo, Claudio, Guerrero, Rodolfo Ahuad, Schygiel, Pablo, Milesi, Rodolfo, Sosa, Carlos, Hominal, Miguel, Marquez, Lilia Lobo, Poy, Carlos, Hasbani, Eduardo, Vico, Marisa, Fernandez, Alberto, Vita, Nestor, Vanhaecke, Johan, De Keulenaer, Gilles, Striekwold, Harry, Vervoort, Geert, Vrolix, Mathias, Henry, Philippe, Dendale, Paul, Smolders, Walter, Marechal, Patrick, Vandekerckhove, Hans, Oliveira, Mucio, Jr., Neuenschwande, Fernando, Reis, Gilmar, Saraiva, Jose, Bodanese, Luiz, Canesin, Manoel, Greco, Oswaldo, Bassan, Roberto, Marino, Roberto Luis, Giannetti, Nadia, Moe, Gordon, Sussex, Bruce, Sheppard, Richard, Huynh, Thao, Stewart, Robert, Haddad, Haissam, Echeverria, Luis, Quintero, Adalberto, Torres, Adriana, Jaramillo, Mónica, Lopez, Mónica, Mendoza, Fernan, Florez, Noel, Cotes, Carlos, Garcia, Magali, Belohlavek, Jan, Hradec, Jaromir, Peterka, Martin, Gregor, Pavel, Monhart, Zdenek, Jansky, Petr, Kettner, Jiri, Reichert, Petr, Spinar, Jindrich, Brabec, Tomas, Hutyra, Martin, Solar, Miroslav, Pietilä, Mikko, Nyman, Kai, Pajari, Risto, Cohen, Ariel, Galinier, Michel, Gosse, Philippe, Livarek, Bernard, Neuder, Yannick, Jourdain, Patrick, Picard, François, Isnard, Richard, Hoppe, Uta, Kaeaeb, Stefan, Rosocha, Stefan, Prondzinsky, Roland, Felix, Stephan, Duengen, Hans-Dirk, Figulla, Hans-Reiner, Fischer, Sven, Behrens, Steffen, Stawowy, Philipp, Kruells-Muench, Juergen, Knebel, Fabian, Nienaber, Christoph, Werner, Dierk, Aron, Wilma, Remppis, Bjoern, Hambrecht, Rainer, Kisters, Klaus, Werner, Nikos, Hoffmann, Stefan, Rossol, Siegbert, Geiss, Ernst, Graf, Kristof, Hamann, Frank, von Scheidt, Wolfgang, Schwinger, Robert, Tebbe, Ulrich, Costard-Jaeckle, Angelika, Lueders, Stephan, Heitzer, Thomas, Leutermann-Oei, Marie-Louise, Braun-Dullaeus, Ruediger, Roehnisch, Jens-Uwe, Muth, Gerhard, Goette, Andreas, Rotter, Achim, Ebelt, Henning, Olbrich, Hans-Georg, Mitrovic, Veselin, Hengstenberg, Christian, Schellong, Sebastian, Zamolyi, Karoly, Vertes, Andras, Matoltsy, Andras, Palinkas, Attila, Herczeg, Bela, Apro, Dezso, Lupkovics, Geza, Tomcsanyi, Janos, Toth, Kalman, Mathur, Atul, Banker, Darshan, Bharani, Anil, Arneja, Jaspal, Khan, Aziz, Gadkari, Milind, Hiremath, Jagdish, Patki, Nitin, Kumbla, Makund, Santosh, M.J., Ravikishore, A.G., Abhaichand, Rajpal, Maniyal, Vijayakukmar, Nanjappa, Manjunath, Reddy, P. Naveen, Chockalingam, Kulasekaran, Premchand, Rajendra, Mahajan, Vijay, Lewis, Basil, Wexler, Dov, Shochat, Michael, Keren, Andre, Omary, Muhamad, Katz, Amos, Marmor, Alon, Lembo, Giuseppe, Di Somma, Salvatore, Boccanelli, Alessandro, Barbiero, Mario, Pajes, Giuseppe, De Servi, Stefano, Greco, Dott Cosimo, De Santis, Fernando, Floresta, Agata, Visconti, Luigi Oltrona, Piovaccari, Giancarlo, Cavallini, Claudio, Di Biase, Matteo, Masini, Dott Franco, Vassanelli, Corrado, Viecca, Maurizio, Cangemi, Dott Francesco, Pirelli, Salvatore, Borghi, Claudio, Volpe, Massimo, Branzi, Angelo, Percoco, Dott Giovanni, Severi, Silvia, Santini, Alberto, De Lorenzi, Ettore, Metra, Marco, Zacà, Valerio, Mortara, Andrea, Tranquilino, Francisco P., Babilonia, Noe A., Ferrolino, Arthur M., Manlutac, Benjamin, Jr, Dluzniewski, Miroslaw, Dzielinska, Zofia, Nowalany-Kozie, Ewa, Mazurek, Walentyna, Wierzchowiecki, Jerzy, Wysokinski, Andrzej, Szachniewicz, Joanna, Romanowski, Witold, Krauze-Wielicka, Magdalena, Jankowski, Piotr, Berkowski, Piotr, Szelemej, Roman, Kleinrok, Andrzej, Kornacewicz-Jac, Zdzislawa, Vintila, Marius, Vladoianu, Mircea, Militaru, Constantin, Dan, Gheorghe, Dorobantu, Maria, Dragulescu, Stefan, Kostenko, Victor, Vishnevsky, Alexandr, Goloschekin, Boris, Tyrenko, Vadim, Gordienko, Alexander, Kislyak, Oxana, Martsevich, Sergey, Kuchmin, Alexey, Karpov, Yurii, Fomin, Igor, Shvarts, Yury, Orlikova, Olga, Ershova, Olga, Berkovich, Olga, Sitnikova, Maria, Pakhomova, Inna, Boldueva, Svetlana, Tyurina, Tatiana, Simanenkov, Vladimir, Boyarkin, Mikhail, Novikova, Nina, Tereschenko, Sergey, Zadionchenko, Vladimir, Shogenov, Zaur, Gordeev, Ivan, Moiseev, Valentin, Wong, Raymond, Ong, Hean Yee, Le Tan, Ju, Goncalvesova, Eva, Kovar, Frantisek, Skalina, Ivan, Kasperova, Viera, Hojerova, Silvia, Szentivanyi, Miroslav, Stancak, Branislav, Babcak, Marian, Kycina, Peter, Poliacik, Pavol, Toth, Peter, Sirotiakova, Jana, de Sa, Esteban Lopez, Bueno, Manuel Gomez, Selles, Manuel Martinez, Cabrera, Jose Angel, Freire, Ramon Bover, Gonzalez Juanatey, Jose Ramon, Comin, Josep, Soriano, FranciscoRidocci, Lopez, Alejandro, Vicho, Raul, Lama, Manuel Geraldia, Schaufelberger, Maria, Brunotte, Richard, Ullman, Bengt, Hagerman, Inger, Cizinsky, Stella, Cherng, Wen-Jin, Yu, Wen-Chung, Kuo, Chi-Tai, Chang, Kuan-Cheng, Lai, Wen-Ter, Kuo, Jen-Yuan, Ural, Dilek, Badak, Ozer, Akin, Mustafa, Yigit, Zerrin, Yokusoglu, Mehmet, Yilmaz, Mehmet, Abaci, Adnan, Ebinc, Haksun, Perlman, Richard, Parish, David, Bergin, James, Burnham, Kenneth, Brown, Christopher, Lundbye, Justin, Williams, Celeste, Eisen, Howard, Juneman, Elizabeth, Joseph, Susan, Peberdy, Mary Ann, Peura, Jennifer, Gupta, Vishal, Habet, Kalim, French, William, Mody, Freny, Graham, Susan, Hazelrigg, Monica, Chung, Eugene, Dunlap, Stephanie, Nikolaidis, Lazaros, Najjar, Samer, Katz, Richard, Murali, Srinivas, Izzo, Joseph L., Callister, Tracy, Phillips, Roland, Lippolis, Nicholas, Winterton, John, Meymandi, Sheba, Heilman, Karl, III, Oren, Ron, Zolty, Ronald, Brottman, Michael, Gunawardena, D.R., Adams, Kirkwood, Barnard, Denise, Klapholz, Marc, and Fulmer, James

Published
2013
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19. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure

Author

Teerlink, John R., primary, Diaz, Rafael, additional, Felker, G. Michael, additional, McMurray, John J.V., additional, Metra, Marco, additional, Solomon, Scott D., additional, Adams, Kirkwood F., additional, Anand, Inder, additional, Arias-Mendoza, Alexandra, additional, Biering-Sørensen, Tor, additional, Böhm, Michael, additional, Bonderman, Diana, additional, Cleland, John G.F., additional, Corbalan, Ramon, additional, Crespo-Leiro, Maria G., additional, Dahlström, Ulf, additional, Echeverria, Luis E., additional, Fang, James C., additional, Filippatos, Gerasimos, additional, Fonseca, Cândida, additional, Goncalvesova, Eva, additional, Goudev, Assen R., additional, Howlett, Jonathan G., additional, Lanfear, David E., additional, Li, Jing, additional, Lund, Mayanna, additional, Macdonald, Peter, additional, Mareev, Viacheslav, additional, Momomura, Shin-ichi, additional, O’Meara, Eileen, additional, Parkhomenko, Alexander, additional, Ponikowski, Piotr, additional, Ramires, Felix J.A., additional, Serpytis, Pranas, additional, Sliwa, Karen, additional, Spinar, Jindrich, additional, Suter, Thomas M., additional, Tomcsanyi, Janos, additional, Vandekerckhove, Hans, additional, Vinereanu, Dragos, additional, Voors, Adriaan A., additional, Yilmaz, Mehmet B., additional, Zannad, Faiez, additional, Sharpsten, Lucie, additional, Legg, Jason C., additional, Varin, Claire, additional, Honarpour, Narimon, additional, Abbasi, Siddique A., additional, Malik, Fady I., additional, and Kurtz, Christopher E., additional

Published
2021
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21. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction:GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials

Author

Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J. V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias-Mendoza, Alexandra, Biering-Sorensen, Tor, Bohm, Michael, Bonderman, Diana, Cleland, John G. F., Corbalan, Ramon, Crespo-Leiro, Maria G., Dahlstrom, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Candida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin-ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., Kurtz, Christopher E., Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J. V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias-Mendoza, Alexandra, Biering-Sorensen, Tor, Bohm, Michael, Bonderman, Diana, Cleland, John G. F., Corbalan, Ramon, Crespo-Leiro, Maria G., Dahlstrom, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Candida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin-ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., and Kurtz, Christopher E.

Abstract

Aims The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is being tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial. Here we describe the baseline characteristics of participants in GALACTIC-HF and how these compare with other contemporary trials.Methods and results Adults with established HFrEF, New York Heart Association (NYHA) functional class >= II, ejection fractionConclusions GALACTIC-HF enrolled a well-treated, high-risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation.

Published
2020

22. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure

Author

Teerlink, John R., Díaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalán, Ramón, Crespo-Leiro, María Generosa, Dahlström, Ulf, Echeverría Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cándida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Li, J., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J.A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Varin, Claire, Honarpour, N., Abbasi, Siddique A., Malik, Fady I., Kurtz, Christopher E., Teerlink, John R., Díaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalán, Ramón, Crespo-Leiro, María Generosa, Dahlström, Ulf, Echeverría Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cándida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Li, J., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J.A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Varin, Claire, Honarpour, N., Abbasi, Siddique A., Malik, Fady I., and Kurtz, Christopher E.

Abstract

[Abstract] BACKGROUND. The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS. We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS. During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P=0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro–B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS. Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016-002299-28.)

Published
2020

23. Relation between baroreflex sensitivity and cardiac vagal tone in humans

Author

Kollai, Mark, Jokkel, Gabor, Bonyhay, Istvan, Tomcsanyi, Janos, and Naszlady, Attila

Subjects
Cardiology -- Research, Atropine -- Research, Biological sciences
Abstract

Experiments on young human subjects reveal that both baroreflex-dependent and baroreflex-independent mechanisms generate cardiac vagal tone in humans. The ratio between the two mechanisms varies in different individuals with the baroreflex-dependent mechanism being the major influence. The change in R-P intervals following complete cholinergic blockade by atropine is designated cardiac vagal tone and regressed against systolic pressure.

Published
1994

28. TCT-804 Comparative Validation of the ALPHA Score, a Novel Risk Model Including Vascular Access Site for Predicting 30-Day Mortality in Patients Treated With Primary PCI

Author

Hizoh, Istvan, primary, Banhegyi, Gyongyver, additional, Domokos, Dominika, additional, Major, Laszlo, additional, Andrassy, Peter, additional, Andreka, Peter, additional, Becker, Dávid, additional, Buttl, Andrea, additional, Cziraki, Attila, additional, Dezsi, Csaba Andras, additional, Edes, Istvan, additional, Forster, Tamas, additional, Herczeg, Bela, additional, Janosi, Andras, additional, Katona, Andras, additional, Kiss, Robert, additional, Koszegi, Zsolt, additional, Lupkovics, Geza, additional, Nagy, Gergely, additional, Nagy, Lajos, additional, Noori, Ebrahim, additional, Tomcsanyi, Janos, additional, Veress, Gábor, additional, Ruzsa, Zoltan, additional, and Merkely, Bela, additional

Published
2018
Full Text
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33. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

Author

Maggioni, Aldo P., Greene, Stephen J., Fonarow, Gregg C., Böhm, Michael, Zannad, Faiez, Solomon, Scott D., Lewis, Eldrin F., Baschiera, Fabio, Hua, Tsushung A., Gimpelewicz, Claudio R., Lesogor, Anastasia, Gheorghiade, Mihai, Ramos, Silvina, Luna, Alejandra, Miriuka, Santiago, Diez, Mirta, Perna, Eduardo, Luquez, Hugo, Pinna, Jorge Garcia, Castagnino, Jorge, Alvarenga, Pablo, Ibañez, Julio, Blumberg, Eduardo Salmon, Dizeo, Claudio, Guerrero, Rodolfo Ahuad, Schygiel, Pablo, Milesi, Rodolfo, Sosa, Carlos, Hominal, Miguel, Marquez, Lilia Lobo, Poy, Carlos, Hasbani, Eduardo, Vico, Marisa, Fernandez, Alberto, Vita, Nestor, Vanhaecke, Johan, De Keulenaer, Gilles, Striekwold, Harry, Vervoort, Geert, Vrolix, Mathias, Henry, Philippe, Dendale, Paul, Smolders, Walter, Marechal, Patrick, Vandekerckhove, Hans, Oliveira, Mucio, Neuenschwande, Fernando, Reis, Gilmar, Saraiva, Jose, Bodanese, Luiz, Canesin, Manoel, Greco, Oswaldo, Bassan, Roberto, Marino, Roberto Luis, Giannetti, Nadia, Moe, Gordon, Sussex, Bruce, Sheppard, Richard, Huynh, Thao, Stewart, Robert, Haddad, Haissam, Echeverria, Luis, Quintero, Adalberto, Torres, Adriana, Jaramillo, Mónica, Lopez, Mónica, Mendoza, Fernan, Florez, Noel, Cotes, Carlos, Garcia, Magali, Belohlavek, Jan, Hradec, Jaromir, Peterka, Martin, Gregor, Pavel, Monhart, Zdenek, Jansky, Petr, Kettner, Jiri, Reichert, Petr, Spinar, Jindrich, Brabec, Tomas, Hutyra, Martin, Solar, Miroslav, Pietilä, Mikko, Nyman, Kai, Pajari, Risto, Cohen, Ariel, Galinier, Michel, Gosse, Philippe, Livarek, Bernard, Neuder, Yannick, Jourdain, Patrick, Picard, François, Isnard, Richard, Hoppe, Uta, Kaeaeb, Stefan, Rosocha, Stefan, Prondzinsky, Roland, Felix, Stephan, Duengen, Hans-Dirk, Figulla, Hans-Reiner, Fischer, Sven, Behrens, Steffen, Stawowy, Philipp, Kruells-Muench, Juergen, Knebel, Fabian, Nienaber, Christoph, Werner, Dierk, Aron, Wilma, Remppis, Bjoern, Hambrecht, Rainer, Kisters, Klaus, Werner, Nikos, Hoffmann, Stefan, Rossol, Siegbert, Geiss, Ernst, Graf, Kristof, Hamann, Frank, von Scheidt, Wolfgang, Schwinger, Robert, Tebbe, Ulrich, Costard-Jaeckle, Angelika, Lueders, Stephan, Heitzer, Thomas, Leutermann-Oei, Marie-Louise, Braun-Dullaeus, Ruediger, Roehnisch, Jens-Uwe, Muth, Gerhard, Goette, Andreas, Rotter, Achim, Ebelt, Henning, Olbrich, Hans-Georg, Mitrovic, Veselin, Hengstenberg, Christian, Schellong, Sebastian, Zamolyi, Karoly, Vertes, Andras, Matoltsy, Andras, Palinkas, Attila, Herczeg, Bela, Apro, Dezso, Lupkovics, Geza, Tomcsanyi, Janos, Toth, Kalman, Mathur, Atul, Banker, Darshan, Bharani, Anil, Arneja, Jaspal, Khan, Aziz, Gadkari, Milind, Hiremath, Jagdish, Patki, Nitin, Kumbla, Makund, Santosh, M.J., Ravikishore, A.G., Abhaichand, Rajpal, Maniyal, Vijayakukmar, Nanjappa, Manjunath, Reddy, P. Naveen, Chockalingam, Kulasekaran, Premchand, Rajendra, Mahajan, Vijay, Lewis, Basil, Wexler, Dov, Shochat, Michael, Keren, Andre, Omary, Muhamad, Katz, Amos, Marmor, Alon, Lembo, Giuseppe, Di Somma, Salvatore, Boccanelli, Alessandro, Barbiero, Mario, Pajes, Giuseppe, De Servi, Stefano, Greco, Dott Cosimo, De Santis, Fernando, Floresta, Agata, Visconti, Luigi Oltrona, Piovaccari, Giancarlo, Cavallini, Claudio, Di Biase, Matteo, Masini, Dott Franco, Vassanelli, Corrado, Viecca, Maurizio, Cangemi, Dott Francesco, Pirelli, Salvatore, Borghi, Claudio, Volpe, Massimo, Branzi, Angelo, Percoco, Dott Giovanni, Severi, Silvia, Santini, Alberto, De Lorenzi, Ettore, Metra, Marco, Zacà, Valerio, Mortara, Andrea, Tranquilino, Francisco P., Babilonia, Noe A., Ferrolino, Arthur M., Manlutac, Benjamin, Dluzniewski, Miroslaw, Dzielinska, Zofia, Nowalany-Kozie, Ewa, Mazurek, Walentyna, Wierzchowiecki, Jerzy, Wysokinski, Andrzej, Szachniewicz, Joanna, Romanowski, Witold, Krauze-Wielicka, Magdalena, Jankowski, Piotr, Berkowski, Piotr, Szelemej, Roman, Kleinrok, Andrzej, Kornacewicz-Jac, Zdzislawa, Vintila, Marius, Vladoianu, Mircea, Militaru, Constantin, Dan, Gheorghe, Dorobantu, Maria, Dragulescu, Stefan, Kostenko, Victor, Vishnevsky, Alexandr, Goloschekin, Boris, Tyrenko, Vadim, Gordienko, Alexander, Kislyak, Oxana, Martsevich, Sergey, Kuchmin, Alexey, Karpov, Yurii, Fomin, Igor, Shvarts, Yury, Orlikova, Olga, Ershova, Olga, Berkovich, Olga, Sitnikova, Maria, Pakhomova, Inna, Boldueva, Svetlana, Tyurina, Tatiana, Simanenkov, Vladimir, Boyarkin, Mikhail, Novikova, Nina, Tereschenko, Sergey, Zadionchenko, Vladimir, Shogenov, Zaur, Gordeev, Ivan, Moiseev, Valentin, Wong, Raymond, Ong, Hean Yee, Le Tan, Ju, Goncalvesova, Eva, Kovar, Frantisek, Skalina, Ivan, Kasperova, Viera, Hojerova, Silvia, Szentivanyi, Miroslav, Stancak, Branislav, Babcak, Marian, Kycina, Peter, Poliacik, Pavol, Toth, Peter, Sirotiakova, Jana, de Sa, Esteban Lopez, Bueno, Manuel Gomez, Selles, Manuel Martinez, Cabrera, Jose Angel, Freire, Ramon Bover, Gonzalez Juanatey, Jose Ramon, Comin, Josep, Soriano, FranciscoRidocci, Lopez, Alejandro, Vicho, Raul, Lama, Manuel Geraldia, Schaufelberger, Maria, Brunotte, Richard, Ullman, Bengt, Hagerman, Inger, Cizinsky, Stella, Cherng, Wen-Jin, Yu, Wen-Chung, Kuo, Chi-Tai, Chang, Kuan-Cheng, Lai, Wen-Ter, Kuo, Jen-Yuan, Ural, Dilek, Badak, Ozer, Akin, Mustafa, Yigit, Zerrin, Yokusoglu, Mehmet, Yilmaz, Mehmet, Abaci, Adnan, Ebinc, Haksun, Perlman, Richard, Parish, David, Bergin, James, Burnham, Kenneth, Brown, Christopher, Lundbye, Justin, Williams, Celeste, Eisen, Howard, Juneman, Elizabeth, Joseph, Susan, Peberdy, Mary Ann, Peura, Jennifer, Gupta, Vishal, Habet, Kalim, French, William, Mody, Freny, Graham, Susan, Hazelrigg, Monica, Chung, Eugene, Dunlap, Stephanie, Nikolaidis, Lazaros, Najjar, Samer, Katz, Richard, Murali, Srinivas, Izzo, Joseph L., Callister, Tracy, Phillips, Roland, Lippolis, Nicholas, Winterton, John, Meymandi, Sheba, Heilman, Karl, Oren, Ron, Zolty, Ronald, Brottman, Michael, Gunawardena, D.R., Adams, Kirkwood, Barnard, Denise, Klapholz, Marc, Fulmer, James, Maggioni, Aldo P., Greene, Stephen J., Fonarow, Gregg C., Böhm, Michael, Zannad, Faiez, Solomon, Scott D., Lewis, Eldrin F., Baschiera, Fabio, Hua, Tsushung A., Gimpelewicz, Claudio R., Lesogor, Anastasia, Gheorghiade, Mihai, Ramos, Silvina, Luna, Alejandra, Miriuka, Santiago, Diez, Mirta, Perna, Eduardo, Luquez, Hugo, Pinna, Jorge Garcia, Castagnino, Jorge, Alvarenga, Pablo, Ibañez, Julio, Blumberg, Eduardo Salmon, Dizeo, Claudio, Guerrero, Rodolfo Ahuad, Schygiel, Pablo, Milesi, Rodolfo, Sosa, Carlos, Hominal, Miguel, Marquez, Lilia Lobo, Poy, Carlos, Hasbani, Eduardo, Vico, Marisa, Fernandez, Alberto, Vita, Nestor, Vanhaecke, Johan, De Keulenaer, Gilles, Striekwold, Harry, Vervoort, Geert, Vrolix, Mathias, Henry, Philippe, Dendale, Paul, Smolders, Walter, Marechal, Patrick, Vandekerckhove, Hans, Oliveira, Mucio, Neuenschwande, Fernando, Reis, Gilmar, Saraiva, Jose, Bodanese, Luiz, Canesin, Manoel, Greco, Oswaldo, Bassan, Roberto, Marino, Roberto Luis, Giannetti, Nadia, Moe, Gordon, Sussex, Bruce, Sheppard, Richard, Huynh, Thao, Stewart, Robert, Haddad, Haissam, Echeverria, Luis, Quintero, Adalberto, Torres, Adriana, Jaramillo, Mónica, Lopez, Mónica, Mendoza, Fernan, Florez, Noel, Cotes, Carlos, Garcia, Magali, Belohlavek, Jan, Hradec, Jaromir, Peterka, Martin, Gregor, Pavel, Monhart, Zdenek, Jansky, Petr, Kettner, Jiri, Reichert, Petr, Spinar, Jindrich, Brabec, Tomas, Hutyra, Martin, Solar, Miroslav, Pietilä, Mikko, Nyman, Kai, Pajari, Risto, Cohen, Ariel, Galinier, Michel, Gosse, Philippe, Livarek, Bernard, Neuder, Yannick, Jourdain, Patrick, Picard, François, Isnard, Richard, Hoppe, Uta, Kaeaeb, Stefan, Rosocha, Stefan, Prondzinsky, Roland, Felix, Stephan, Duengen, Hans-Dirk, Figulla, Hans-Reiner, Fischer, Sven, Behrens, Steffen, Stawowy, Philipp, Kruells-Muench, Juergen, Knebel, Fabian, Nienaber, Christoph, Werner, Dierk, Aron, Wilma, Remppis, Bjoern, Hambrecht, Rainer, Kisters, Klaus, Werner, Nikos, Hoffmann, Stefan, Rossol, Siegbert, Geiss, Ernst, Graf, Kristof, Hamann, Frank, von Scheidt, Wolfgang, Schwinger, Robert, Tebbe, Ulrich, Costard-Jaeckle, Angelika, Lueders, Stephan, Heitzer, Thomas, Leutermann-Oei, Marie-Louise, Braun-Dullaeus, Ruediger, Roehnisch, Jens-Uwe, Muth, Gerhard, Goette, Andreas, Rotter, Achim, Ebelt, Henning, Olbrich, Hans-Georg, Mitrovic, Veselin, Hengstenberg, Christian, Schellong, Sebastian, Zamolyi, Karoly, Vertes, Andras, Matoltsy, Andras, Palinkas, Attila, Herczeg, Bela, Apro, Dezso, Lupkovics, Geza, Tomcsanyi, Janos, Toth, Kalman, Mathur, Atul, Banker, Darshan, Bharani, Anil, Arneja, Jaspal, Khan, Aziz, Gadkari, Milind, Hiremath, Jagdish, Patki, Nitin, Kumbla, Makund, Santosh, M.J., Ravikishore, A.G., Abhaichand, Rajpal, Maniyal, Vijayakukmar, Nanjappa, Manjunath, Reddy, P. Naveen, Chockalingam, Kulasekaran, Premchand, Rajendra, Mahajan, Vijay, Lewis, Basil, Wexler, Dov, Shochat, Michael, Keren, Andre, Omary, Muhamad, Katz, Amos, Marmor, Alon, Lembo, Giuseppe, Di Somma, Salvatore, Boccanelli, Alessandro, Barbiero, Mario, Pajes, Giuseppe, De Servi, Stefano, Greco, Dott Cosimo, De Santis, Fernando, Floresta, Agata, Visconti, Luigi Oltrona, Piovaccari, Giancarlo, Cavallini, Claudio, Di Biase, Matteo, Masini, Dott Franco, Vassanelli, Corrado, Viecca, Maurizio, Cangemi, Dott Francesco, Pirelli, Salvatore, Borghi, Claudio, Volpe, Massimo, Branzi, Angelo, Percoco, Dott Giovanni, Severi, Silvia, Santini, Alberto, De Lorenzi, Ettore, Metra, Marco, Zacà, Valerio, Mortara, Andrea, Tranquilino, Francisco P., Babilonia, Noe A., Ferrolino, Arthur M., Manlutac, Benjamin, Dluzniewski, Miroslaw, Dzielinska, Zofia, Nowalany-Kozie, Ewa, Mazurek, Walentyna, Wierzchowiecki, Jerzy, Wysokinski, Andrzej, Szachniewicz, Joanna, Romanowski, Witold, Krauze-Wielicka, Magdalena, Jankowski, Piotr, Berkowski, Piotr, Szelemej, Roman, Kleinrok, Andrzej, Kornacewicz-Jac, Zdzislawa, Vintila, Marius, Vladoianu, Mircea, Militaru, Constantin, Dan, Gheorghe, Dorobantu, Maria, Dragulescu, Stefan, Kostenko, Victor, Vishnevsky, Alexandr, Goloschekin, Boris, Tyrenko, Vadim, Gordienko, Alexander, Kislyak, Oxana, Martsevich, Sergey, Kuchmin, Alexey, Karpov, Yurii, Fomin, Igor, Shvarts, Yury, Orlikova, Olga, Ershova, Olga, Berkovich, Olga, Sitnikova, Maria, Pakhomova, Inna, Boldueva, Svetlana, Tyurina, Tatiana, Simanenkov, Vladimir, Boyarkin, Mikhail, Novikova, Nina, Tereschenko, Sergey, Zadionchenko, Vladimir, Shogenov, Zaur, Gordeev, Ivan, Moiseev, Valentin, Wong, Raymond, Ong, Hean Yee, Le Tan, Ju, Goncalvesova, Eva, Kovar, Frantisek, Skalina, Ivan, Kasperova, Viera, Hojerova, Silvia, Szentivanyi, Miroslav, Stancak, Branislav, Babcak, Marian, Kycina, Peter, Poliacik, Pavol, Toth, Peter, Sirotiakova, Jana, de Sa, Esteban Lopez, Bueno, Manuel Gomez, Selles, Manuel Martinez, Cabrera, Jose Angel, Freire, Ramon Bover, Gonzalez Juanatey, Jose Ramon, Comin, Josep, Soriano, FranciscoRidocci, Lopez, Alejandro, Vicho, Raul, Lama, Manuel Geraldia, Schaufelberger, Maria, Brunotte, Richard, Ullman, Bengt, Hagerman, Inger, Cizinsky, Stella, Cherng, Wen-Jin, Yu, Wen-Chung, Kuo, Chi-Tai, Chang, Kuan-Cheng, Lai, Wen-Ter, Kuo, Jen-Yuan, Ural, Dilek, Badak, Ozer, Akin, Mustafa, Yigit, Zerrin, Yokusoglu, Mehmet, Yilmaz, Mehmet, Abaci, Adnan, Ebinc, Haksun, Perlman, Richard, Parish, David, Bergin, James, Burnham, Kenneth, Brown, Christopher, Lundbye, Justin, Williams, Celeste, Eisen, Howard, Juneman, Elizabeth, Joseph, Susan, Peberdy, Mary Ann, Peura, Jennifer, Gupta, Vishal, Habet, Kalim, French, William, Mody, Freny, Graham, Susan, Hazelrigg, Monica, Chung, Eugene, Dunlap, Stephanie, Nikolaidis, Lazaros, Najjar, Samer, Katz, Richard, Murali, Srinivas, Izzo, Joseph L., Callister, Tracy, Phillips, Roland, Lippolis, Nicholas, Winterton, John, Meymandi, Sheba, Heilman, Karl, Oren, Ron, Zolty, Ronald, Brottman, Michael, Gunawardena, D.R., Adams, Kirkwood, Barnard, Denise, Klapholz, Marc, and Fulmer, James

Abstract

Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64-0.99; DM: HR: 1.16, 95% CI: 0.91-1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50-0.94; DM: HR: 1.64, 95% CI: 1.15-2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71-1.93; DM: HR: 2.39, 95% CI: 1.30-4.42; P = 0.0

Published
2017

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