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2. Efficacy of omecamtiv mecarbil in heart failure with reduced ejection fraction according to N-terminal pro-B-type natriuretic peptide level: Insights from the GALACTIC-HF trial
- Author
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Docherty, Kieran F, Mcmurray, John J V, Claggett, Brian L, Miao, Zi Michael, Adams, Kirkwood F, Arias-Mendoza, Alexandra, Cleland, John G F, Diaz, Rafael, Echeverria Correa, Luis E, Felker, G Michael, Fonseca, Candida, Li, WEN JING, Metra, Marco, Sliwa-Hahnle, Karen, Solomon, Scott D, Vandekerckhove, Hans J, Vinereanu, Dragos, Voors, Adriaan A, Heitner, Stephen B, Kupfer, Stuart, Malik, Fady I, Meng, Lisa, and Teerlink, John R
- Subjects
Pharmacology ,Treatment ,Calcium cycling/excitation-contraction coupling ,Mortality/survival ,Heart failure ,Acute coronary syndromes ,Cardiology and Cardiovascular Medicine ,Atrial fibrillation - Abstract
N-terminal pro-B-type natriuretic peptide (NT-proBNP) is predictive of both outcomes and response to treatment in patients with heart failure with reduced ejection fraction (HFrEF).To examine the effect of the cardiac myosin activator omecamtiv mecarbil according to baseline NT-proBNP level in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure trial (GALACTIC-HF).The primary outcome was the composite of a worsening HF event (urgent clinic visit, emergency department visit, or hospitalization) or cardiovascular death. We prespecified analysis of the effect of treatment according to baseline NT-proBNP (≤median,median), excluding individuals with AF/AFL.Of the 8232 patients analyzed, 8206 had an available baseline NT-proBNP measurement. Among the 5971 patients not in AF/AFL, the median (Q1, Q3) NT-proBNP level was 1675 (812-3579) pg/ml. Hazard ratios (HR) for the effect of omecamtiv mecarbil, compared with placebo, for the primary endpoint in patients without AF/AFL were: ≤median 0.94 (95% CI, 0.80-1.09),median 0.81 (0.73-0.90) [P-interaction = 0.095]; for the overall population (including patients with AF/AFL) the HRs were ≤ median 1.01 (0.90-1.15) and median 0.88 (0.80-0.96) [P-interaction = 0.035]. There was an interaction between treatment and NT-proBNP, examined as a continuous variable, with greater effect of omecamtiv mecarbil on the primary outcome in patients with a higher baseline NT-proBNP (P-interaction = 0.086).In GALACTIC-HF, the benefit of omecamtiv mecarbil appeared to be larger in patients with higher baseline NT-proBNP levels, especially in patients without AF/AFL. This article is protected by copyright. All rights reserved.
- Published
- 2022
3. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials
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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, 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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
4. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction:GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials
- Author
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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
5. Síndrome de encefalopatía posterior reversible secundaria a tacrolimus
- Author
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Rodríguez-González, María J., Calvo-Betancourt, Lauren S., and Echeverría-Correa, Luis E.
- Published
- 2016
- Full Text
- View/download PDF
6. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial
- Author
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Faiez Zannad, Andreas J. Flammer, Lars Køber, Yoshihiko Saito, Inder S. Anand, Turia Ben-Gal, Adel R. Rizkala, Davor Miličić, Hans Dirk Duengen, Nancy K. Sweitzer, Junbo Ge, Jiří Widimský, Tzvetana Katova, Robert Zweiker, Chen Huan Chen, Sergio V. Perrone, Margaret M. Redfield, Sanjiv J. Shah, Michael R. Zile, Milton Packer, Jean L. Rouleau, Felipe Martinez, Michele Senni, Juan Luis Arango, Gerard Linssen, Eileen O'Meara, Vijay K. Chopra, Aldo P. Maggioni, Josep Comín-Colet, Bojan Vrtovec, Stefan D. Anker, Jyrki Taurio, Armando Godoy, Scott D. Solomon, Jingmin Zhou, David Sim, Małgorzata Lelonek, Dragos Vinereanu, Michel Galinier, John J.V. McMurray, Carolyn S.P. Lam, Naresh Ranjith, Burkert Pieske, Nagesh S. Anavekar, Béla Merkely, Jose L. Arenas, Sergey Boytsov, John G.F. Cleland, José Francisco Kerr Saraiva, Stefan Janssens, Jianjian Gong, Victor Shi, Dirk J. van Veldhuisen, Eva Goncalvesova, Antonio S. Sibulo, Petar M. Seferovic, Martin Lefkowitz, Byung Hee Oh, Mehmet Yilmaz, Luis E. Echeverría Correa, Marc A. Pfeffer, Lars Lund, Dan Atar, Gerasimos Filippatos, Cardiovascular Centre (CVC), Solomon, S, Rizkala, A, Lefkowitz, M, Shi, V, Gong, J, Anavekar, N, Anker, S, Arango, J, Arenas, J, Atar, D, Ben-Gal, T, Boytsov, S, Chen, C, Chopra, V, Cleland, J, Comin-Colet, J, Duengen, H, Echeverria Correa, L, Filippatos, G, Flammer, A, Galinier, M, Godoy, A, Goncalvesova, E, Janssens, S, Katova, T, Kober, L, Lelonek, M, Linssen, G, Lund, L, O'Meara, E, Merkely, B, Milicic, D, Oh, B, Perrone, S, Ranjith, N, Saito, Y, Saraiva, J, Shah, S, Seferovic, P, Senni, M, Sibulo, A, Sim, D, Sweitzer, N, Taurio, J, Vinereanu, D, Vrtovec, B, Widimsky, J, Yilmaz, M, Zhou, J, Zweiker, R, Anand, I, Ge, J, Lam, C, Maggioni, A, Martinez, F, Packer, M, Pfeffer, M, Pieske, B, Redfield, M, Rouleau, J, Van Veldhuisen, D, Zannad, F, Zile, M, Mcmurray, J, [Solomon, Scott D. -- Pfeffer, Marc A.] Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, Boston, MA 02115 USA -- [Rizkala, Adel R. -- Lefkowitz, Martin P. -- Shi, Victor C. -- Gong, JianJian] Novartis Pharmaceut, E Hanover, NJ USA -- [Anavekar, Nagesh] Univ Melbourne, Fac Med Dent & Hlth Sci, Melbourne, Vic, Australia -- [Anker, Stefan D.] Charite Univ Med Berlin, Deutsch Zentrum Herz Kreislauf Forsch DZHK Berlin, Div Cardiol & Metab, Dept Cardiol CVK, Berlin, Germany -- [Anker, Stefan D.] Charite Univ Med Berlin, Deutsch Zentrum Herz Kreislauf Forsch DZHK Berlin, Berlin Brandenburg Ctr Regenerat Therapies BCRT, Berlin, Germany -- [Anker, Stefan D.] Univ Gottingen, Med Ctr, Dept Cardiol & Pneumol, Gottingen, Germany -- [Arango, Juan L.] Guatemalan Heart Inst, San Luis Potosi, Mexico -- [Arango, Juan L.] Ctr Atenc & Invest Cardiovasc Potosi SC, San Luis Potosi, Mexico -- [Arango, Juan L.] Hosp Angeles San Luis, San Luis Potosi, Mexico -- [Atar, Dan] Univ Oslo, Dept Cardiol B, Oslo, Norway -- [Ben-Gal, Turia] Rabin Med Ctr, Cardiol Dept, Heart Failure Unit, Petah Tiqwa, Israel -- [Boytsov, Sergey A.] Minist Hlth Russian Federat, Natl Res Ctr Cardiol, Moscow, Russia -- [Chen, Chen-Huan] Natl Yang Ming Univ, Dept Med, Taipei, Taiwan -- [Chopra, Vijay K.] Medanta Med, Heart Failure Unit, Gurugram, Haryana, India -- [Cleland, John] Univ Glasgow, Inst Hlth & Wellbeing, Robertson Ctr Biostat & Clin Trials, Glasgow, Lanark, Scotland -- [McMurray, John J. V.] Univ Glasgow, British Heart Fdn, Cardiovasc Res Ctr, Glasgow, Lanark, Scotland -- [Cleland, John] Imperial Coll, Royal Brompton & Harefield Hosp, Natl Heart & Lung Inst, London, England -- [Comin-Colet, Josep] Univ Barcelona, Bellvitge Univ Hosp, Dept Cardiol, Community Heart Failure Program, Barcelona, Spain -- [Comin-Colet, Josep] Univ Barcelona, Inst Invest Biomed Bellvitge, Barcelona, Spain -- [Duengen, Hans-Dirk -- Pieske, Burkert] Univ Med Berlin, Cardiol Charite, Dept Internal Med, Campus Virchow Klinikum Berlin, Berlin, Germany -- [Echeverria Correa, Luis E.] Fdn Cardiovasc Colombia, Heart Failure Unit, Santander, Spain -- [Echeverria Correa, Luis E.] Fdn Cardiovasc Colombia, Cardiac Transplant Program, Santander, Spain -- [Filippatos, Gerasimos] Univ Athens, Attikon Univ Hosp, Athens, Greece -- [Filippatos, Gerasimos] Univ Cyprus, Sch Med, Athens, Greece -- [Flammer, Andreas J.] Univ Hosp Zurich, Univ Heart Ctr Zurich, Dept Cardiol, Zurich, Switzerland -- [Galinier, Michel] Rangueil Univ Hosp, Dept Cardiol, Toulouse, France -- [Godoy, Armando] Univ Nacl Mayor San Marcos, Lima, Peru -- [Godoy, Armando] Inst Nacl Cardiovasc INCOR, Lima, Peru -- [Godoy, Armando] Scientia Clin & Epidemiol Res Inst, Trujillo, Peru -- [Goncalvesova, Eva] Natl Cardiovasc Inst, Dept Heart Failure Transplantat, Bratislava, Slovakia -- [Janssens, Stefan] Univ Hosp Leuven, Dept Cardiol, Leuven, Belgium -- [Katova, Tzvetana] Natl Cardiol Hosp, Clin Cardiol, Sofia, Bulgaria -- [Saraiva, Jose F.] Pontificia Univ Catolica Campinas, Fac Med, Disciplina Cardiol, Sao Paulo, Brazil -- [Kober, Lars] Copenhagen Univ Hosp, Rigshosp, Heart Ctr, Dept Cardiol, Copenhagen, Denmark -- [Lelonek, Malgorzata] Med Univ Lodz, Dept Noninvas Cardiol, Lodz, Poland -- [Linssen, Gerard] Hosp Grp Twente, Dept Cardiol, Almelo, Netherlands -- [Linssen, Gerard] Hosp Grp Twente, Dept Cardiol, Hengelo, Netherlands -- [Lund, Lars H.] Karolinska Univ Hosp, Karolinska Inst & Heart & Vasc Theme, Dept Med, Stockholm, Sweden -- [O'Meara, Eileen -- Rouleau, Jean L.] Univ Montreal, Inst Cardiol Montreal, Montreal, PQ, Canada -- [Merkely, Bela] Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary -- [Milicic, Davor] Univ Hosp Ctr Zagreb, Dept Cardiovasc Dis, Zagreb, Croatia -- [Oh, Byung-Hee] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Seoul, South Korea -- [Perrone, Sergio V.] Inst FLENI, Buenos Aires, DF, Argentina -- [Ranjith, Naresh] City Hosp, Dept Cardiol, Durban, South Africa -- [Saito, Yoshihiko] Nara Med Univ, Dept Internal Med 1, Kashihara, Nara, Japan -- [Shah, Sanjiv] Northwestern Univ, Feinberg Sch Med, Dept Med, Div Cardiol, Chicago, IL 60611 USA -- [Seferovic, Petar M.] Univ Belgrade, Med Ctr, Univ Belgrade, Dept Cardiol,Sch Med, Belgrade, Serbia -- [Senni, Michele] Hosp Papa Giovanni XXIII, Cardiovasc Dept, Cardiol Div, Bergamo, Italy -- [Sibulo, Antonio S., Jr.] St Lukes Med Ctr, St Lukes Heart Inst, Taguig, Philippines -- [Sim, David] Natl Heart Ctr Singapore, Dept Cardiol, Singapore, Singapore -- [Sweitzer, Nancy K.] Univ Arizona, Coll Med, Sarver Heart Ctr, Tucson, AZ USA -- [Taurio, Jyrki] Tampere Univ Hosp, Dept Cardiol, Tampere, Finland -- [Vinereanu, Dragos] Univ Med & Pharm Carol Davila, Univ & Emergency Hosp Bucharest, Bucharest, Romania -- [Vrtovec, Bojan] Univ Med Ctr, Ljubljana, Slovenia -- [Widimsky, Jiri] Charles Univ Prague, Fac Med 1, Prague, Czech Republic -- [Yilmaz, Mehmet B.] Cumhuriyet Univ, Fac Med, Dept Cardiol, Sivas, Turkey -- [Zhou, Jingmin] Tongji Univ, Sch Med, Tongji Hosp, Dept Cardiol, Shanghai, Peoples R China -- [Zweiker, Robert] Med Univ Graz, Dept Cardiol, Graz, Austria -- [Anand, Inder S.] VA Med Ctr, Dept Med, Minneapolis, MN USA -- [Anand, Inder S.] Univ Minnesota, Minneapolis, MN USA -- [Ge, Junbo] Fudan Univ, Zhongshan Hosp, Shanghai Inst Cardiovasc Dis, Shanghai, Peoples R China -- [Lam, Carolyn S. P.] Natl Heart Ctr Singapore, Singapore, Singapore -- [Lam, Carolyn S. P.] Duke Natl Univ Singapore, Singapore, Singapore -- [Maggioni, Aldo P.] Associaz Nazl Med Cardiol Osped, Florence, Italy -- [Martinez, Felipe] Univ Nacl Cordoba, Cordoba, Argentina -- [Packer, Milton] Baylor Univ, Med Ctr, Baylor Heart & Vasc Inst, Dallas, TX USA -- [Redfield, Margaret M.] Mayo Clin, Dept Cardiovasc Med, Rochester, MN USA -- [Van Veldhuisen, Dirk J.] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands -- [Zannad, Faiez] INSERM, CIC 1433, Nancy, France -- [Zannad, Faiez] Univ Lorraine, CHR Univ, Nancy, France -- [Zile, Michael R.] Med Univ South Carolina, Charleston, SC 29425 USA -- [Zile, Michael R.] Ralph H Johnson Vet Adm, Med Ctr, Charleston, SC USA, Boytsov, Sergey -- 0000-0001-6998-8406, Maggioni, Aldo Pietro -- 0000-0003-2764-6779, and Anand, Inder -- 0000-0003-1308-4963
- Subjects
Male ,medicine.medical_specialty ,Angiotensin receptor ,Adrenergic beta-Antagonists ,Diastole ,heart failure ,Angiotensin-Converting Enzyme Inhibitors ,030204 cardiovascular system & hematology ,heart failure, diastolic ,Ventricular Function, Left ,03 medical and health sciences ,NEPRILYSIN INHIBITION ,0302 clinical medicine ,Internal medicine ,angiotensin receptor antagonists ,Medicine ,Humans ,030212 general & internal medicine ,10. No inequality ,endopeptidase ,Aged ,Mineralocorticoid Receptor Antagonists ,Aged, 80 and over ,antagonists ,Clinical Trials as Topic ,OUTCOMES ,Ejection fraction ,Angiotensin Receptor Antagonists ,business.industry ,Stroke Volume ,clinical trial ,Middle Aged ,angiotensin receptor ,medicine.disease ,3. Good health ,Clinical trial ,endopeptidases ,angiotensin receptor antagonist ,diastolic ,Baseline characteristics ,Heart failure ,Cardiology ,Valsartan ,Female ,Cardiology and Cardiovascular Medicine ,business ,Angiotensin II Type 1 Receptor Blockers - Abstract
WOS: 000438926500008, PubMed ID: 29980595, BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality. METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7 +/- 8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had >= 1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), beta-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease. CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics., Novartis, The PARAGON-HF trial is funded by Novartis.
- Published
- 2018
7. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials.
- Author
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Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sørensen T, Böhm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlström U, Echeverria Correa LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Abbasi SA, Varin C, Malik FI, and Kurtz CE
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic, Stroke Volume drug effects, Urea therapeutic use, Ventricular Function, Left drug effects, Heart Failure drug therapy, Heart Failure physiopathology, Urea analogs & derivatives
- 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 fraction ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization/emergency department visit for heart failure within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic-guided dosing: 25, 37.5, or 50 mg bid). A total of 8256 patients [male (79%), non-white (22%), mean age 65 years] were enrolled with a mean ejection fraction 27%, ischaemic aetiology in 54%, NYHA class II 53% and III/IV 47%, and median N-terminal pro-B-type natriuretic peptide 1971 pg/mL. Heart failure therapies at baseline were among the most effectively employed in contemporary heart failure trials. GALACTIC-HF randomized patients representative of recent heart failure 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 <100 mmHg (n = 1127), estimated glomerular filtration rate <30 mL/min/1.73 m
2 (n = 528), and treated with sacubitril/valsartan at baseline (n = 1594)., Conclusions: 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., (© 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)- Published
- 2020
- Full Text
- View/download PDF
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