Status:
RECRUITING
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
Lead Sponsor:
Pfizer
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
All participants in this study will take either the study medicine (PF-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. The study determines if the study medicine (...
Eligibility Criteria
Inclusion
- This study is seeking participants who are:
- Key Inclusion Criteria include:
- aged 18 years or older.
- \- 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%
- Body mass index of 27 kg/m2 or higher
- Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score \< 85
- Six-minute walking distance greater than 75 meters
- Key Exclusion Criteria include:
- 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
Exclusion
Key Trial Info
Start Date :
June 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2027
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT06991257
Start Date
June 19 2025
End Date
December 14 2027
Last Update
August 14 2025
Active Locations (24)
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1
National Heart Institute
Beverly Hills, California, United States, 90211
2
Orange County Research Center
Lake Forest, California, United States, 92630
3
FWD Clinical Research
Boca Raton, Florida, United States, 33486
4
Amavita Research Services
North Miami Beach, Florida, United States, 33169