RecruitingPhase 2NCT06991257
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN ORAL BRANCHED-CHAIN KETOACID DEHYDROGENASE KINASE INHIBITOR, PF-07328948, IN ADULTS WITH HEART FAILURE (BRANCH-HF)
Sponsor
Pfizer
Enrollment
620 participants
Start Date
Jun 19, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 79 Years
Inclusion Criteria7
- This study is seeking participants who are:
- aged 18 years to \< 80 years
- clinically confirmed to have a diagnosis of heart failure for at least 3 months
- New York Heart Association Class II-IV symptoms
- left ventricular ejection fraction greater than 40%
- Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score \< 85
- Six-minute walking distance greater than 75 meters
Exclusion Criteria4
- Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
- Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.
- History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
- Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor
Interventions
DRUGPlacebo
ARM 1
DRUGLow Dose PF-07328948
ARM 2
DRUGMedium Dose PF-07328948
ARM 3
DRUGHigh Dose PF-07328948
ARM 4
Locations(125)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06991257
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