Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory

Ankeet S Bhatt; William T Abraham; JoAnn Lindenfeld; Michael Bristow; Peter E Carson; G Michael Felker; Gregg C Fonarow; Stephen J Greene; Mitchell A Psotka; Scott D Solomon; Norman Stockbridge; John R Teerlink; Muthiah Vaduganathan; Janet Wittes; Mona Fiuzat; Christopher M O'Connor; Javed Butler

doi:10.1016/j.jchf.2020.10.014

Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory

JACC Heart Fail. 2021 Jan;9(1):1-12. doi: 10.1016/j.jchf.2020.10.014. Epub 2020 Dec 9.

Authors

Ankeet S Bhatt¹, William T Abraham², JoAnn Lindenfeld³, Michael Bristow⁴, Peter E Carson⁵, G Michael Felker⁶, Gregg C Fonarow⁷, Stephen J Greene⁶, Mitchell A Psotka⁸, Scott D Solomon¹, Norman Stockbridge⁹, John R Teerlink¹⁰, Muthiah Vaduganathan¹, Janet Wittes¹¹, Mona Fiuzat⁶, Christopher M O'Connor⁸, Javed Butler¹²

Affiliations

¹ Cardiology Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.
² Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
³ Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
⁴ Division of Cardiology, University of Colorado, Aurora, Colorado, USA.
⁵ Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC.
⁶ Duke Clinical Research Institute and Division of Cardiology, Duke University, Durham, North Carolina, USA.
⁷ Department of Internal Medicine, University of California-Los Angeles, Los Angeles, California, USA.
⁸ Inova Heart and Vascular Institute, Falls Church, Virginia.
⁹ U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁰ Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, California, USA.
¹¹ Statistics Collaborative, Washington, DC, USA.
¹² Department of Medicine, University of Mississippi, Jackson, Mississippi, USA. Electronic address: jbutler4@umc.edu.

PMID: 33309582
DOI: 10.1016/j.jchf.2020.10.014

Abstract

The treatment of heart failure with reduced ejection fraction (HFrEF) has changed considerably over time, particularly with the sequential development of therapies aimed at antagonism of maladaptive biologic pathways, including inhibition of the sympathetic nervous system and the renin-angiotensin aldosterone system. The sequential nature of earlier HFrEF trials allowed the integration of new therapies tested against the background therapy of the time. More recently, multiple heart failure therapies are being evaluated simultaneously, and the number of therapeutic choices for treating HFrEF has grown considerably. In addition, implementation science has lagged behind discovery science in heart failure. Furthermore, given there are currently >200 ongoing clinical trials in heart failure, further complexities are anticipated. In an effort to provide a decision-making framework in the current era of expanding therapeutic options in HFrEF, the Heart Failure Collaboratory convened a multi-stakeholder group, including patients, clinicians, clinical investigators, the U.S. Food and Drug Administration, industry, and payers who met at the U.S. Food and Drug Administration campus on March 6, 2020. This paper summarizes the discussions and expert consensus recommendations.

Keywords: clinical trials; heart failure; implementation science.

Publication types

Review

MeSH terms

Heart Failure* / drug therapy
Humans
Renin-Angiotensin System
Stroke Volume
Sympathetic Nervous System

Grants and funding

R18 FD006920/FD/FDA HHS/United States