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

NCT ID: NCT06991257

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2027-12-14

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind, placebo-controlled study

Study Groups

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ARM 1

Placebo Participants will receive Placebo for up to 36 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

ARM 1

ARM 2

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

Group Type EXPERIMENTAL

Low Dose PF-07328948

Intervention Type DRUG

ARM 2

ARM 3

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

Group Type EXPERIMENTAL

Medium Dose PF-07328948

Intervention Type DRUG

ARM 3

ARM 4

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

Group Type EXPERIMENTAL

High Dose PF-07328948

Intervention Type DRUG

ARM 4

Interventions

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Placebo

ARM 1

Intervention Type DRUG

Low Dose PF-07328948

ARM 2

Intervention Type DRUG

Medium Dose PF-07328948

ARM 3

Intervention Type DRUG

High Dose PF-07328948

ARM 4

Intervention Type DRUG

Other Intervention Names

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low dose medium dose High dose

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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National Heart Institute

Beverly Hills, California, United States

Site Status RECRUITING

Orange County Research Center

Lake Forest, California, United States

Site Status RECRUITING

Comprehensive Cardiovascular Care

Santa Maria, California, United States

Site Status RECRUITING

FOMAT Medical Research

Santa Maria, California, United States

Site Status RECRUITING

FWD Clinical Research

Boca Raton, Florida, United States

Site Status RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

Infinite Clinical Research

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Amavita Research Services

North Miami Beach, Florida, United States

Site Status RECRUITING

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

Site Status NOT_YET_RECRUITING

Chicago Medical Research

Hazel Crest, Illinois, United States

Site Status NOT_YET_RECRUITING

NexGen Research

Fort Wayne, Indiana, United States

Site Status NOT_YET_RECRUITING

Reid Physician Associates

Richmond, Indiana, United States

Site Status RECRUITING

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Site Status NOT_YET_RECRUITING

Velocity Clinical Research, Lincoln, Pioneer Heart Institute

Lincoln, Nebraska, United States

Site Status RECRUITING

NexGen Research

Lima, Ohio, United States

Site Status NOT_YET_RECRUITING

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, United States

Site Status RECRUITING

Valley Regional Medical Center

Brownsville, Texas, United States

Site Status RECRUITING

North Dallas Research Associates

McKinney, Texas, United States

Site Status NOT_YET_RECRUITING

Northwest Houston Heart Center

Tomball, Texas, United States

Site Status RECRUITING

Diagnostic Consultative Center - 1 Lom EOOD

Lom, Montana, Bulgaria

Site Status RECRUITING

Diagnostic Consultative Center "Ascendent"

Sofia, Sofia (stolitsa), Bulgaria

Site Status RECRUITING

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa), Bulgaria

Site Status RECRUITING

"Multiprofile Hospital for Active Treatment Puls" AD

Blagoevgrad, , Bulgaria

Site Status RECRUITING

Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD

Gabrovo, , Bulgaria

Site Status RECRUITING

Medical Center Hera - Kyustendil EOOD

Kyustendil, , Bulgaria

Site Status RECRUITING

MHAT - Heart and Brain

Pleven, , Bulgaria

Site Status RECRUITING

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv, , Bulgaria

Site Status RECRUITING

MHAT Hadzhi Dimitar

Sliven, , Bulgaria

Site Status NOT_YET_RECRUITING

Richmond Clinical Trials

Richmond, British Columbia, Canada

Site Status RECRUITING

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, Canada

Site Status NOT_YET_RECRUITING

Health Sciences North Research Institute

Greater Sudbury, Ontario, Canada

Site Status NOT_YET_RECRUITING

ACV Clinic

Greater Sudbury, Ontario, Canada

Site Status NOT_YET_RECRUITING

CardioQuest Research Centre

Sarnia, Ontario, Canada

Site Status NOT_YET_RECRUITING

Corcare

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Community Care Building

Winchester, Ontario, Canada

Site Status RECRUITING

Winchester District Memorial Hospital

Winchester, Ontario, Canada

Site Status RECRUITING

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Site Status NOT_YET_RECRUITING

CHU de Quebec - Université Laval - Hotel Dieu de Quebec

Québec, Quebec, Canada

Site Status RECRUITING

Clinique de Médecins Spécialistes

Shebrooke, Quebec, Canada

Site Status RECRUITING

Diex Recherche Sherbrooke Est

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.

Terrebonne, Quebec, Canada

Site Status RECRUITING

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, Canada

Site Status NOT_YET_RECRUITING

Sdružené Zdravotnické Zařízení Krnov

Krnov, Moravskoslezský kraj, Czechia

Site Status RECRUITING

Kardiologicka ambulance Brno s.r.o.

Brno - Kralovo Pole, , Czechia

Site Status RECRUITING

EFERTUS healthcare s.r.o.

Brno-Zidenice, , Czechia

Site Status NOT_YET_RECRUITING

EDUMED s.r.o.

Jaroměř, , Czechia

Site Status RECRUITING

VASOMED Clinic s.r.o.

Ostrava, , Czechia

Site Status RECRUITING

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

Saint-Herblain, Loire-atlantique, France

Site Status NOT_YET_RECRUITING

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, Provence-Alpes-Côte d'Azur Region, France

Site Status NOT_YET_RECRUITING

Chu Grenoble Alpes

Grenoble, , France

Site Status NOT_YET_RECRUITING

Da Vinci Magánklinika

Pécs, Baranya, Hungary

Site Status NOT_YET_RECRUITING

CMed Rehabilitacios es Diagnosztikai Kozpont

Székesfehérvár, Fejér, Hungary

Site Status NOT_YET_RECRUITING

Ezüstfény Klinika Kft

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Semmelweis Egyetem

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Jahn Ferenc Dél-pesti Hospital

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

New Medical Center Kft.

Sopron, , Hungary

Site Status NOT_YET_RECRUITING

Kasugai Municipal Hospital

Kasugai, Aichi-ken, Japan

Site Status RECRUITING

Nagoya Tokushukai General Hospital

Kasugai, Aichi-ken, Japan

Site Status RECRUITING

Seikeikai New Tokyo Heart Clinic

Matsudo, Chiba, Japan

Site Status RECRUITING

Toho University Sakura Medical Center

Sakura, Chiba, Japan

Site Status NOT_YET_RECRUITING

Teine Keijinkai Hospital

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Koga General Hospital

Koga, Ibaraki, Japan

Site Status RECRUITING

Sagamihara Kyodo Hospital

Sagamihara, Kanagawa, Japan

Site Status RECRUITING

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, Japan

Site Status RECRUITING

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

National Hospital Organization Mie Chuo Medical Center

Tsu, Mie-ken, Japan

Site Status RECRUITING

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

Site Status RECRUITING

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Site Status RECRUITING

National Hospital Organization Saitama Hospital

Wako, Saitama, Japan

Site Status RECRUITING

Tokyo Metropolitan Toshima Hospital

Itabashi-ku, Tokyo, Japan

Site Status RECRUITING

Showa General Hospital

Kodaira-shi, Tokyo, Japan

Site Status RECRUITING

National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo, Japan

Site Status RECRUITING

NewHeart Watanabe Institute

Suginami, Tokyo, Japan

Site Status RECRUITING

Sekino Hospital

Toshimaku, Tokyo, Japan

Site Status RECRUITING

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Yamaguchi, Japan

Site Status RECRUITING

Nagasaki Harbor Medical Center

Nagasaki, , Japan

Site Status RECRUITING

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

SP ZOZ w Puławach

Puławy, Lublin Voivodeship, Poland

Site Status RECRUITING

NZOZ Sopockie Centrum Badan Kardiologicznych Pro Cordis Pawel Miekus

Sopot, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Kardio Brynow

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Research and Cardiovascular Corp.

Ponce, , Puerto Rico

Site Status NOT_YET_RECRUITING

Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [barcelona], Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain

Site Status NOT_YET_RECRUITING

Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat, Spain

Site Status NOT_YET_RECRUITING

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Ninewells Hospital and Medical School

Dundee, Dundee CITY, United Kingdom

Site Status NOT_YET_RECRUITING

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

Site Status NOT_YET_RECRUITING

St Richard's Hospital

Chichester, WEST Sussex, United Kingdom

Site Status NOT_YET_RECRUITING

South Eastern Health and Social Care Trust

Belfast, , United Kingdom

Site Status NOT_YET_RECRUITING

Wycombe General Hospital

High Wycombe, , United Kingdom

Site Status RECRUITING

Countries

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United States Bulgaria Canada Czechia France Hungary Japan Poland Puerto Rico Spain United Kingdom

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=C4921003

To obtain contact information for a study center near you, click here.

Other Identifiers

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2024-518438-94-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4921003

Identifier Type: -

Identifier Source: org_study_id

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