Abstract
The last decade of acute heart failure (HF) research is characterized by disappointments in large phase 2 and 3 pharmacologic studies of therapeutics including calcium-sensitizing agents and antagonists of endothelin, vasopressin, and adenosine. As a result, pharmacologic management for acute HF has changed little in recent years, and adverse event rates remain higher than in chronic HF. Despite neutral results in many acute HF trials, recent studies including RELAX-AHF, ASTRONAUT, and PRONTO have highlighted the role of appropriate timing of patient enrollment, targeting the "right" patients, and selecting appropriate end points and sites. We describe lessons learned from recent trials in acute HF and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, and regulatory representatives at the 9th Global Cardio Vascular Clinical Trialists Forum in Paris, France, from November 30 to December 1, 2012.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 629-635 |
| Number of pages | 7 |
| Journal | American heart journal |
| Volume | 166 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 2013 |
Funding
No extramural funding was used to support this work. G.M.F. has received consulting fees from Novartis, Medpace, Amgen, Otsuka, Trevena, Roche Diagnostics, Merck, BG Medicine, Medtronic, and St Jude, and grant funding from Amgen, Otsuka, Roche Diagnostics, and NHLBI. W.F.P. has received research grants from Abbott, Alere, Brahms, Novartis, Roche, and The Medicine's Company; is a consultant for Abbott, Alere, BG, Cardiorentis, GE, Jannsen, Lily, The Medicine's Company, Singulex, and Verathon; and served on the speaker's bureaus of Abbott, Alere, Astra Zeneca, and Daichi-Sankyo; and has received ownership interest from Comprehensive Research Associates LLC, Vital Sensors, and Emergencies in Medicine LLC. B.P. has received consulting fees from Pfizer, Merck, Novartis, Takeda, Astra Zeneca, Bayer, Lilly, BMS, Cytopherx, Amorcyte, Relypsa, BG Medicine, Aurasense, and GE-Health Care; stocks options from Relypsa, BG Medicine, and Aurasense; and grant support from Novartis, Forrest Laboratories, and Medtronic. A.P.M. has received consulting fees from Bayer, Amgen, Cardiorentis, and J&J; grants support from Novartis, Medtronic, and Abbott; and consulting fees/travel support from Novartis Pharma. M.G. has received consulting fees from Abbott Laboratories, Astellas, AstraZeneca, Bayer Schering Pharma, Bayer HealthCare, Cardiorentis, CorThera, Cytokinetics, CytoPherx, DebioPharm, Errekappa Terapeutici, GlaxoSmithKline, Ikaria, Intersection Medical, INC, J&J, Medtronic, Merck, Novartis Pharma, Ono Pharma USA, Otsuka Pharmaceuticals, Palatin Technologies, Pericor Therapeutics, Protein Design Laboratories, sanofi-aventis, Sigma Tau, Solvay Pharmaceuticals, Sticares InterACT, Takeda Pharmaceuticals, and Trevena Therapeutics. S.P. has received grant support from Astra Zeneca and Pfizer. F.Z. has received grants support from Novartis, BG Medicine, and Roche Diagnostics; has served on the speakers' bureaus from Pfizer and AstraZeneca; is a board member of Boston Scientific; and has received consulting fees from Novartis, Takeda, AstraZeneca, Boehringer-Ingelheim, GE Healthcare, Relypsa, Servier, Boston Scientific, Bayer, Johnson & Johnson, and ResMed. The other authors report no relevant conflicts. The authors are solely responsible for the drafting and editing of the manuscript and its final contents.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine