Standard Baseline Therapy Needed For HF Patients in Clinical Trials

There should be a standard baseline drug therapy against which new therapies are studied for patients with heart failure (HF), according to a review paper published Jan. 31 in the Journal of the American College of Cardiology.

Mona Fiuzat, PharmD, FACC, et al., summarize a March 2021 meeting of the Heart Failure Collaboratory, convened to discuss to discuss whether a standardization of background drug therapy is necessary for clinical trials in HF patients. The Heart Failure Collaboratory is a consortium of clinical investigators, clinicians and patients, as well as representatives from U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry. The authors also provide potential conceptual approaches, focusing on therapies for HF with reduced ejection fraction.

The authors explain regulatory considerations related to drugs and devices for testing new therapies against guideline-directed medical therapy (GMDT) or “usual care,” which varies because patients are often undertreated. The authors note that the expert panel agreed that “encouraging the best tolerated background GDMT in clinical trials fosters best practice and may facilitate maximization of therapy.” The review outlines potential approaches to standardize baseline treatment, including specific drug class recommendations; GDMT scoring systems; and other strategies that meet the needs of trialists, sponsors, regulators, payers, patients and prescribers.

According to the authors, there is “agreement” that “some standard of baseline drug therapy is important for studying new therapies” and that it “would be ethically untenable for trial participants to be enrolled without any background GDMT.” They note that “the more the baseline drug therapy is constrained, the less opportunity there may be to understand interactions, to determine the need for additional and alternative therapies, or to evaluate new mechanisms.” There is a “wide range of options” to determine the standard baseline drug therapy, they add, concluding that the review provides “several concepts as to how this question might be approached in future clinical trials.”

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