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NCT06991257PHASE2Recruiting

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

Pfizer

Start Date

6/19/2025

Completion Date

12/14/2027

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 (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.

Eligibility Criteria

Age Range: 18 years to 79 years

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

Interventions

DRUG

Placebo

DRUG

Low Dose PF-07328948

DRUG

Medium Dose PF-07328948

DRUG

High Dose PF-07328948

Interested in This Trial?

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Conditions

Heart Failure

Locations

National Heart Institute

Beverly Hills, California 90211

United States

Orange County Research Center

Lake Forest, California 92630

United States

Comprehensive Cardiovascular Care

Santa Maria, California 93454

United States

FOMAT Medical Research

Santa Maria, California 93454

United States

FWD Clinical Research

Boca Raton, Florida 33486

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Infinite Clinical Research

Miami, Florida 33133

United States

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Miami, Florida 33138

United States

Amavita Research Services

North Miami Beach, Florida 33169

United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida 32789

United States

NMH Clinical Research Unit

Chicago, Illinois 60611

United States

Northwestern Memorial HealthCare - Arkes Pavilion

Chicago, Illinois 60611

United States

Northwestern Memorial HealthCare - Feinberg Pavilion

Chicago, Illinois 60611

United States

Northwestern Memorial HealthCare - Galter Pavilion

Chicago, Illinois 60611

United States

Northwestern Memorial Hospital Investigational Drug Service (IDS)

Chicago, Illinois 60611

United States

Northwestern University

Evanston, Illinois 60208

United States

Chicago Medical Research

Hazel Crest, Illinois 60429

United States

NexGen Research

Fort Wayne, Indiana 46804

United States

Reid Physician Associates

Richmond, Indiana 47374

United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland 21229

United States

Chesapeake Cardiac Care

Bowie, Maryland 20715

United States

Flourish Research - Bowie

Bowie, Maryland 20715

United States

Velocity Clinical Research, Lincoln, Pioneer Heart Institute

Lincoln, Nebraska 68510

United States

NexGen Research

Lima, Ohio 45801

United States

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas 78526

United States

Valley Regional Medical Center

Brownsville, Texas 78526

United States

North Dallas Research Associates

McKinney, Texas 75069

United States

Northwest Houston Heart Center

Tomball, Texas 77375

United States

L2IP - Instituto de Pesquisas Clínicas

Brasília, Federal District 70.200-730

Brazil

L2IP - Instituto de Pesquisas Clínicas

Brasília, Federal District 70200730

Brazil

Cardresearch - Cardiologia Assistencial e Pesquisa

Belo Horizonte, Minas Gerais 30150-274

Brazil

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90430-001

Brazil

CoraCentro Pesquisa Clinica

Porto Alegre, Rio Grande do Sul 90840-440

Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, São Paulo 13060-080

Brazil

Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping

Ribeirão Preto, São Paulo 14026-900

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo 15090000

Brazil

UNESP - Faculdade de Medicina da Universidade Estadual Paulista

Botucatu, SÃO PAUL 18618-970

Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010

Brazil

Incor - Instituto do Coracao

São Paulo, 05403-000

Brazil

Diagnostic Consultative Center - 1 Lom EOOD

Lom, Montana 3600

Bulgaria

Diagnostic Consultative Center "Ascendent"

Sofia, Sofia (stolitsa) 1202

Bulgaria

Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD

Sofia, Sofia (stolitsa) 1233

Bulgaria

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa) 1431

Bulgaria

University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD

Sofia, Sofia (stolitsa) 1431

Bulgaria

"Multiprofile Hospital for Active Treatment Puls" AD

Blagoevgrad, 2700

Bulgaria

Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD

Gabrovo, 5300

Bulgaria

Medical Center Hera - Kyustendil EOOD

Kyustendil, 2500

Bulgaria

MHAT - Heart and Brain

Pleven, 5804

Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv, 4002

Bulgaria

MHAT Hadzhi Dimitar

Sliven, 8800

Bulgaria

Аcibadem City Clinic University MHAT EOOD - Third Clinical Base

Sofia, 1415

Bulgaria

Medical Center Hera EOOD

Sofia, 1510

Bulgaria

Richmond Clinical Trials

Richmond, British Columbia V6V 2L1

Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia B3H 3A7

Canada

Health Sciences North Research Institute

Greater Sudbury, Ontario P3E 5J1

Canada

ACV Clinic

Greater Sudbury, Ontario P3E 5M4

Canada

CardioQuest Research Centre

Sarnia, Ontario N7T 4P5

Canada

Corcare

Toronto, Ontario M1B 5N1

Canada

Community Care Building

Winchester, Ontario K0C 2K0

Canada

Winchester District Memorial Hospital

Winchester, Ontario K0C 2K0

Canada

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec G7H 5H6

Canada

CHU de Quebec - Université Laval - Hotel Dieu de Quebec

Québec, Quebec G1R 2J6

Canada

Clinique de Médecins Spécialistes

Shebrooke, Quebec J1E 0N8

Canada

Diex Recherche Sherbrooke Est

Sherbrooke, Quebec J1E 0N8

Canada

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

Terrebonne, Quebec J6V 2H2

Canada

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec G9A 4P3

Canada

Peking University First Hospital

Beijing, Beijing Municipality 100034

China

Lanzhou university second hospital

Lanzhou, Gansu 730030

China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong 510080

China

Hainan General Hospital

Haikou, Hainan 570311

China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei 050031

China

The Second Xiangya Hospital of Central South University

Changsha, Hunan 410011

China

China-Japan Union Hospital

Changchun, Jilin 130033

China

Shaanxi provincial people's hospital

Xi'an, Shaanxi 710068

China

Jinan Central Hospital

Jinan, Shandong 250013

China

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality 200032

China

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality 200065

China

Tianjin People' s Hospital

Tianjin, Tianjin Municipality 300000

China

The First Affiliated Hospital of University of South China

Hengyang,

China

Sdružené Zdravotnické Zařízení Krnov

Krnov, Moravian-Silesian Region 794 01

Czechia

Kardiologicka ambulance Brno s.r.o.

Brno-Královo Pole, 612 00

Czechia

EFERTUS healthcare s.r.o.

Brno-Židenice, 615 00

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

EDUMED s.r.o.

Jaroměř, 551 01

Czechia

VASOMED Clinic s.r.o.

Ostrava, 710 00

Czechia

AGEL Stredomoravska nemocnicni, a.s., Nemocnice AGEL Prerov

Přerov, 751 52

Czechia

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault 34090

France

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

Saint-Herblain, Loire-atlantique 44800

France

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, Provence-Alpes-Côte d'Azur Region 83100

France

Chu Grenoble Alpes

Grenoble, 38700

France

Da Vinci Magánklinika

Pécs, Baranya 7635

Hungary

CMed Rehabilitacios es Diagnosztikai Kozpont

Székesfehérvár, Fejér 8000

Hungary

BKS Research Kft

Hatvan, Heves County 3000

Hungary

Ezüstfény Klinika Kft

Budapest, 1106

Hungary

Semmelweis Egyetem

Budapest, 1122

Hungary

Eszak-Pesti Centrumkorhaz-Honvedkorhaz

Budapest, 1134

Hungary

Jahn Ferenc Dél-pesti Hospital

Budapest, 1204

Hungary

New Medical Center Kft.

Sopron, H-9400

Hungary

Kasugai Municipal Hospital

Kasugai, Aichi-ken 486-8510

Japan

Nagoya Tokushukai General Hospital

Kasugai, Aichi-ken 487-0016

Japan

Seikeikai New Tokyo Heart Clinic

Matsudo, Chiba 271-0077

Japan

Toho University Sakura Medical Center

Sakura, Chiba 285-8741

Japan

Teine Keijinkai Hospital

Sapporo, Hokkaido 006-8555

Japan

Koga General Hospital

Koga, Ibaraki 306-0041

Japan

Sagamihara Kyodo Hospital

Sagamihara, Kanagawa 252-5188

Japan

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa 221-0855

Japan

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa 245-8575

Japan

National Hospital Organization Mie Chuo Medical Center

Tsu, Mie-ken 514-1101

Japan

National Hospital Organization Sendai Medical Center

Sendai, Miyagi 983-8520

Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka 596-0042

Japan

National Hospital Organization Saitama Hospital

Wako, Saitama 351-0102

Japan

Tokyo Metropolitan Toshima Hospital

Itabashi-ku, Tokyo 173-0015

Japan

Showa General Hospital

Kodaira-shi, Tokyo 187-8510

Japan

National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo 152-8902

Japan

NewHeart Watanabe Institute

Suginami, Tokyo 168-0065

Japan

Sekino Hospital

Toshimaku, Tokyo 171-0014

Japan

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Yamaguchi 740-8510

Japan

Nagasaki Harbor Medical Center

Nagasaki, 850-8555

Japan

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship 61-848

Poland

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-231

Poland

Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu

Torun, Kuyavian-Pomeranian Voivodeship 87-100

Poland

SP ZOZ w Puławach

Puławy, Lublin Voivodeship 24-100

Poland

NZOZ Sopockie Centrum Badan Kardiologicznych Pro Cordis Pawel Miekus

Sopot, Pomeranian Voivodeship 81-717

Poland

Kardio Brynow

Katowice, Silesian Voivodeship 40-555

Poland

Research and Cardiovascular Corp.

Ponce, 00717

Puerto Rico

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña] 15706

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [barcelona] 08003

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona] 08035

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [cataluña] 08041

Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalunya [cataluña] 08907

Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid 28220

Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de 28034

Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de 28046

Spain

Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat 46010

Spain

Hospital General Universitario de Valencia

Valencia, 46014

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Ninewells Hospital and Medical School

Dundee, Dundee CITY DD1 9SY

United Kingdom

St. George's Hospital

London, England SW17 0QT

United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk NR4 7UY

United Kingdom

St Richard's Hospital

Chichester, WEST Sussex PO19 6SE

United Kingdom

South Eastern Health and Social Care Trust

Belfast, BT16 1RH

United Kingdom

Wycombe General Hospital

High Wycombe, HP11 2TT

United Kingdom