| Literature DB >> 35115106 |
Mona Fiuzat1, Carine E Hamo2, Javed Butler3, William T Abraham4, Ersilia M DeFilippis5, Gregg C Fonarow6, Joann Lindenfeld7, Robert J Mentz8, Mitchell A Psotka9, Scott D Solomon10, John R Teerlink11, Muthiah Vaduganathan12, Orly Vardeny13, John J V McMurray14, Christopher M O'Connor15.
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.Entities:
Keywords: FDA; HFrEF; clinical trials; device therapy; drug therapy; guideline directed medical therapy; heart failure; medical therapy; medication
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Year: 2022 PMID： 35115106 PMCID： PMC9180686 DOI： 10.1016/j.jacc.2021.11.033
Source DB: PubMed Journal: J Am Coll Cardiol ISSN： 0735-1097 Impact factor: 27.203