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

18-79 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 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
  • Key

Exclusion

  • 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

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

March 3 2026

Active Locations (116)

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Page 1 of 29 (116 locations)

1

National Heart Institute

Beverly Hills, California, United States, 90211

2

Orange County Research Center

Lake Forest, California, United States, 92630

3

Comprehensive Cardiovascular Care

Santa Maria, California, United States, 93454

4

FOMAT Medical Research

Santa Maria, California, United States, 93454