Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week

Mona Fiuzat, Carine E. Hamo, Javed Butler, William T. Abraham, Ersilia M. DeFilippis, Gregg C. Fonarow, Joann Lindenfeld, Robert J. Mentz, Mitchell A. Psotka, Scott D. Solomon, John R. Teerlink, Muthiah Vaduganathan, Orly Vardeny, John J.V. McMurray, Christopher M. O'Connor

Research output: Contribution to journalReview articlepeer-review

23 Scopus citations

Abstract

With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.

Original languageEnglish (US)
Pages (from-to)504-510
Number of pages7
JournalJournal of the American College of Cardiology
Volume79
Issue number5
DOIs
StatePublished - Feb 8 2022

Bibliographical note

Funding Information:
Dr Hamo has received support from the National Heart, Lung, and Blood Institute, National Institutes of Health (grant number T32 HL007024). Dr Butler has served as a consultant to Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Berlin Cures, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sequanna, and Vifor. Dr Fonarow has served as a consultant for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis. Dr Vaduganathan has received research grant support or served on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Relypsa, and Roche Diagnostics; has speaker engagements with Novartis and Roche Diagnostics; and has participated on clinical endpoint committees for studies sponsored by Galmed and Novartis. Dr Solomon has received research grants from Actelion, AstraZeneca, Corvia, Novartis, and Pfizer; and has received consulting fees from Abbott, Actelion, AstraZeneca, Amgen, Axon Therapeutics, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiora, CVRx, Cytokinetics, Edwards, Eisai, Ionis, Ironwood, Merck, MyoKardia, Novartis, Prothena, Pfizer, Regeneron, Sanofi, Shifamed, Tenax, and United Therapeutics. Dr Lindenfeld has served as a consultant for AstraZeneca, Abbott, Allegiant, Boehringer Ingelheim, Boston Scientific, CVRx, Edwards, Impulse Dynamics, and VWave; and has received grants from AstraZeneca, Volumetrix, and Sensible Medical. Dr Abraham has received consulting fees from Abbott, ARCA biopharma, Boehringer Ingelheim, Cardionomic, CVRx, Edwards Lifesciences, Respicardia, Sensible Medical, and Vectorious; and has received salary support from V-Wave Medical. Dr Teerlink has received research grants and/or consulting fees from Abbott, AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, EBR Systems, Medtronic, Merck, and Novartis. Dr McMurray has had payments to his employer, Glasgow University, for his work on clinical trials, consulting and other activities from Alnylam, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardurion, Cytokinetics, Dal-Cor, GlaxoSmithKline, Ionis, KBP Biosciences, Novartis, Pfizer, and Theracos; and has received personal payments from Abbott, Alkem Metabolics, Eris Lifesciences, Hikma, Ionis, Lupin, ProAdWise Communications, Sun Pharmaceuticals, and Servier. Dr O’Connor has received grant or research support from Roche Diagnostics and Merck; and has received consulting fees from Merck, Bayer, Bristol Myers Squibb, Windtree, and Arena. All other authors have reported that they have no relationships related to the contents of this paper to disclose.

Publisher Copyright:
© 2022 The Authors

Keywords

  • FDA
  • HFrEF
  • clinical trials
  • device therapy
  • drug therapy
  • guideline directed medical therapy
  • heart failure
  • medical therapy
  • medication

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural
  • Review

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