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

Purpose

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).

Condition

  • Heart Failure

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind, placebo-controlled study

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
ARM 1 		Placebo Participants will receive Placebo for up to 36 weeks
  • Drug: Placebo
    ARM 1
Experimental
ARM 2 		Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks
  • Drug: Low Dose PF-07328948
    ARM 2
    Other names:
    • low dose
Experimental
ARM 3 		Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks
  • Drug: Medium Dose PF-07328948
    ARM 3
    Other names:
    • medium dose
Experimental
ARM 4 		High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks
  • Drug: High Dose PF-07328948
    ARM 4
    Other names:
    • High dose

Recruiting Locations

National Heart Institute
Beverly Hills, California 90211

Orange County Research Center
Lake Forest, California 92630

Comprehensive Cardiovascular Care
Santa Maria, California 93454

FOMAT Medical Research
Santa Maria, California 93454

FWD Clinical Research
Boca Raton, Florida 33486

Amavita Research Services
North Miami Beach, Florida 33169

Reid Physician Associates
Richmond, Indiana 47374

Velocity Clinical Research, Lincoln, Pioneer Heart Institute
Lincoln, Nebraska 68510

Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas 78526

Valley Regional Medical Center
Brownsville, Texas 78526

North Dallas Research Associates
McKinney, Texas 75069

Northwest Houston Heart Center
Tomball, Texas 77375

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

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 (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.