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1. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study

Author

Gniot, Jacek, Mozheiko, Maria, Lelonek, Malgorzata, Dominguez, Antonio Reyes, Horacek, Thomas, Garcia del Rio, Enrique, Kobalava, Zhanna, Mueller, Christian Eugen, Cavusoglu, Yuksel, Straburzynska-Migaj, Ewa, Slanina, Miroslav, vom Dahl, Juergen, Senni, Michele, Ryding, Alisdair, Moriarty, Andrew, Robles, Manuel Beltran, Villota, Julio Nunez, Quintana, Antonio Garcia, Nitschke, Thorsten, Garcia Pinilla, Jose Manuel, Bonet, Luis Almenar, Chaaban, Said, Filali zaatari, Samia, Spinar, Jindrich, Musial, Wlodzimierz, Abdelbaki, Khaled, Belohlavek, Jan, Fehske, Wolfgang, Bott, Michael Carlos, Hoegalmen, Geir, Leiro, Marisa Crespo, Ozcan, Ismail Turkay, Mullens, Wilfried, Kryza, Radim, Al-Ani, Riadh, Loboz-Grudzien, Krystyna, Ermoshkina, Lyudmila, Hojerova, Silvia, Fernandez, Alberto Alfredo, Spinarova, Lenka, Lapp, Harald, Bulut, Efraim, Almeida, Filipa, Vishnevsky, Alexander, Belicova, Margita, Pascual, Domingo, Witte, Klaus, Wong, Kenneth, Droogne, Walter, Delforge, Marc, Peterka, Martin, Olbrich, Hans-Georg, Carugo, Stefano, Nessler, Jadwiga, McGill, Thao Huynh, Huegl, Burkhard, Akin, Ibrahim, Moreira, Ilidio, Baglikov, Andrey, Thambyrajah, Jeetendra, Hayes, Chris, Barrionuevo, Marcelo Raul, Yigit, Zerrin, Kaya, Hakki, Klimsa, Zdenek, Radvan, Martin, Kadel, Christoph, Landmesser, Ulf, Di Tano, Giuseppe, Lisik, Malgorzata Buksinska, Fonseca, Candida, Oliveira, Luis, Marques, Irene, Santos, Luis Miguel, Lenner, Egon, Letavay, Peter, Bueno, Manuel Gomez, Mota, Paula, Wong, Aaron, Bailey, Kristian, Foley, Paul, Hasbani, Eduardo, Virani, Sean, Massih, Tony Abdel, Al-Saif, Shukri, Taborsky, Milos, Kaislerova, Marta, Motovska, Zuzana, Cohen, Aron Ariel, Logeart, Damien, Endemann, Dierk, Ferreira, Daniel, Brito, Dulce, Kycina, Peter, Bollano, Entela, Basilio, Enrique Galve, Rubio, Lorenzo Facila, Aguado, Marcos Garcia, Schiavi, Lilia Beatriz, Zivano, Daniel Francisco, Lonn, Eva, El Sayed, Ali, Pouleur, Anne-Catherine, Heyse, Alex, Schee, Alexandr, Polasek, Rostislav, Houra, Marek, Tribouilloy, Christophe, Seronde, Marie France, Galinier, Michel, Noutsias, Michel, Schwimmbeck, Peter, Voigt, Ingo, Westermann, Dirk, Pulignano, Giovanni, Vegsundvaag, Johnny, Da Silva Antunes, Jose Alexandre, Monteiro, Pedro, Stevlik, Jan, Goncalvesova, Eva, Hulkoova, Beata, Castro Fernandez, Antonio Juan, Davies, Ceri, Squire, Iain, Meyer, Philippe, Sheppard, Richard, Sahin, Tayfun, Sochor, Karel, De Geeter, Guillaume, Wachter, Rolf, Schmeisser, Alexander, Weil, Joachim, Soares, Ana Oliveira, Vasilevna, Olga Bulashova, Oshurkov, Andrey, Sunderland, Shahid Junejo, Glover, Jason, Exequiel, Tomas, Decoulx, Eric, Meyer, Sven, Muenzel, Thomas, Frioes, Fernando, Arbolishvili, Georgy, Tokarcikova, Anna, Karlstrom, Patric, Trullas Vila, Joan Carles, Perez, Gonzalo Pena, Sankaranarayanan, Rajiv, Nageh, Thuraia, Alasia, Diego Cristian, Refaat, Marwan, Demirkan, Burcu, Al-Buraiki, Jehad, Karabsheh, Shadi, Pascual-Figal, Domingo, Bao, Weibin, Noè, Adele, Schwende, Heike, Butylin, Dmytro, and Prescott, Margaret F.

Published
2020
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2. International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF): rationale for and design of a global registry

Author

Filippatos, Gerasimos, Khan, Sadiya Sana, Ambrosy, Andrew P., Cleland, John G.F., Collins, Sean P., Lam, Carolyn S.P., Angermann, Christiane E., Ertl, Georg, Dahlström, Ulf, Hu, Dayi, Dickstein, Kenneth, Perrone, Sergio V., Ghadanfar, Mathieu, Bermann, Georgina, Noe, Adele, Schweizer, Anja, Maier, Thomas, and Gheorghiade, Mihai

Published
2015
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4. Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study.

Author

Senni, Michele, Wachter, Rolf, Witte, Klaus K., Straburzynska‐Migaj, Ewa, Belohlavek, Jan, Fonseca, Candida, Mueller, Christian, Lonn, Eva, Chakrabarti, Arhit, Bao, Weibin, Noe, Adele, Schwende, Heike, Butylin, Dmytro, Pascual‐Figal, Domingo, Straburzynska-Migaj, Ewa, Pascual-Figal, Domingo, and TRANSITION Investigators

Subjects
HEART failure patients, FAILURE analysis, HEART failure, CLINICAL trial registries, SUBGROUP analysis (Experimental design), TERMINATION of treatment, ENTRESTO, AMINOBUTYRIC acid, PATIENT aftercare, RESEARCH, COMBINATION drug therapy, RESEARCH methodology, BIPHENYL compounds, MEDICAL cooperation, EVALUATION research, COMPARATIVE studies, RANDOMIZED controlled trials, STATISTICAL sampling, DISCHARGE planning
Abstract

Aims: Sacubitril/valsartan has shown efficacy and tolerability in patients with heart failure (HF) and reduced ejection fraction (HFrEF) in the ambulatory setting (PARADIGM-HF), and following stabilisation of acutely decompensated HF (ADHF) (PIONEER-HF and TRANSITION). However, data are lacking for the initiation of sacubitril/valsartan in newly diagnosed (de novo) HFrEF. Here, we assess the tolerability of initiating sacubitril/valsartan following ADHF in TRANSITION subgroups of patients with a de novo vs. prior diagnosis of HFrEF.Methods and Results: TRANSITION randomised 1002 patients to pre- and post-discharge initiation of sacubitril/valsartan (analysis set n = 991, following exclusions for mis-randomisation). In this post-hoc analysis, tolerability to sacubitril/valsartan [proportion of patients achieving target dose (97/103 mg b.i.d.) at 10 weeks post-randomisation], adverse events (AEs) and serious AEs (SAEs) were compared in de novo (n = 286) and prior HFrEF (n = 705) subgroups. More de novo than prior HFrEF patients achieved target dose at Week 10 (56% vs. 45%; relative risk ratio 1.30, 95% confidence interval 1.12-1.52, P < 0.001), and fewer had SAEs and permanent treatment discontinuations. Initiation of sacubitril/valsartan did not prevent the concomitant initiation and up-titration of guideline-directed HF therapies. De novo patients showed faster and greater decreases in N-terminal pro-B-type natriuretic peptide and high-sensitivity troponin-T, and lower rates of HF and all-cause rehospitalisation vs. prior HFrEF.Conclusions: After ADHF, first-line initiation of sacubitril/valsartan in de novo HFrEF, alongside the initiation of other guideline-directed therapies, is feasible and is associated with a better risk-benefit profile than in patients with prior HFrEF. Early intervention with sacubitril/valsartan may be considered to delay disease progression in patients with de novo HFrEF.Clinical Trial Registration: ClinicalTrials.gov, NCT02661217. [ABSTRACT FROM AUTHOR]

Published
2020
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5. International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF): rationale for and design of a global registry

Author

Filippatos, Gerasimos Khan, Sadiya Sana Ambrosy, Andrew P. and Cleland, John G. F. Collins, Sean P. Lam, Carolyn S. P. and Angermann, Christiane E. Ertl, Georg Dahlstrom, Ulf Hu, Dayi and Dickstein, Kenneth Perrone, Sergio V. Ghadanfar, Mathieu and Bermann, Georgina Noe, Adele Schweizer, Anja Maier, Thomas and Gheorghiade, Mihai

Abstract

AimsThe clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF (International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure) is a global, prospective, and observational study designed to characterize patient trajectories longitudinally during and following an index hospitalization for HF. MethodsData collection for the registry will be conducted at approximate to 300 sites located in approximate to 40 countries. Comprehensive data including demographics, clinical presentation, co-morbidities, treatment patterns, quality of life, in-hospital and post-discharge outcomes, and health utilization and costs will be collected. Enrolment of approximate to 20 000 adult patients hospitalized with new-onset (first diagnosis) HF or decompensation of chronic HF over a 3-year period is planned with subsequent 3 years follow-up. PerspectiveThe REPORT-HF registry will explore the clinical characteristics, management, and outcomes of HF worldwide. This global research programme may have implications for the formulation of public health policy and the design and conduct of international clinical trials.

Published
2015

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