A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)

Condition(s) studied

Investigational drug(s) / intervention(s)

Placebo: ARM 1

Low Dose PF-07328948: ARM 2

Medium Dose PF-07328948: ARM 3

High Dose PF-07328948: ARM 4

Study summary

The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).

Eligibility

Primary outcome measure(s)

• Number of Participants with Clinical Events — over 36 weeks
  Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
• Change From Baseline in 6-Minute Walk Test (6MWD) — Baseline, week 36 post-dose
  A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
• Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) — Baseline, week 36
  KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.

Trial sites (150)

+ 110 more sites — see the full list on the official registry below.

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