Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials
Mona Fiuzat, Carine 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
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.