Elsevier

JACC: Heart Failure

Volume 9, Issue 1, January 2021, Pages 1-12
JACC: Heart Failure

Mini-Focus: Guideline-Directed Medical Therapy (GDMT)
JACC: Heart Failure Expert Panel Paper
Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory

https://doi.org/10.1016/j.jchf.2020.10.014Get rights and content
Under a Creative Commons license
open access

Highlights

  • Due to advances in discovery science, the number of pharmacological choices for treating heart failure with reduced ejection fraction has grown considerably.

  • Currently, comprehensive disease-modifying therapy focused on implementation of evidenced-based therapies modifying 5 biologic pathways with 4 therapeutic agents should be prioritized.

  • Development of an implementation framework to promote more rapid uptake of these therapies requires broad stakeholder cooperation and investment.

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.

Key Words

clinical trials
heart failure
implementation science

Abbreviations and Acronyms

ACE
angiotensin-converting enzyme
ARB
angiotensin receptor blocker
ARNI
angiotensin receptor neprilysin inhibitor
GDMT
guideline-directed medical therapy
HF
heart failure
LVEF
left ventricular ejection fraction
MRA
mineralocorticoid receptor antagonist
SGLT2
sodium-glucose cotransporter 2

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The views expressed in this paper are those of the authors and do not necessarily represent the views of the U.S. Food and Drug Administration or the United States Department of Health and Human Services. Barry Greenberg, MD, served as Guest Editor for this paper.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.