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

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Heart Failure

Treatments: Drug: Medium Dose PF-07328948; Drug: Placebo; Drug: Low Dose PF-07328948; Drug: High Dose PF-07328948

Study type: Interventional

Funder types: Industry

Identifiers

NCT06991257

C4921003

2024-518438-94-00 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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 (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard-of-care medications for heart failure that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants will be involved in this study for about 48 weeks. During this time, participants will visit the study clinic 15 times. In general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.

Enrollment: 620 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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620 participants in 4 patient groups, including a placebo group

ARM 1

Placebo Comparator group

Description:

Placebo Participants will receive Placebo for up to 36 weeks

Treatment:

Drug: Placebo

ARM 2

Experimental group

Description:

Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Treatment:

Drug: Low Dose PF-07328948

ARM 3

Experimental group

Description:

Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Treatment:

Drug: Medium Dose PF-07328948

ARM 4

Experimental group

Description:

High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Treatment:

Drug: High Dose PF-07328948