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

J Am Coll Cardiol. 2022 Feb 8;79(5):504-510. doi: 10.1016/j.jacc.2021.11.033.


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.

Keywords: FDA; HFrEF; clinical trials; device therapy; drug therapy; guideline directed medical therapy; heart failure; medical therapy; medication.

Publication types

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

MeSH terms

  • Cardiovascular Agents / therapeutic use*
  • Clinical Trials as Topic*
  • Heart Failure / drug therapy*
  • Heart Failure / physiopathology
  • Humans
  • Periodicals as Topic*
  • Stroke Volume / physiology*


  • Cardiovascular Agents