Treatment of HF in an Era of Multiple Therapies
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
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.