A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
Phase 2 – studying effectiveness and dosage
Conditions:
Heart Failure
Sponsor: Pfizer
trial.available_in:
БГ
Overview
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).
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.
Who can participate
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
Placebo
DRUG
Low Dose PF-07328948
DRUG
Medium Dose PF-07328948
DRUG
High Dose PF-07328948
DRUG
Locations
133
Brazil (11)
Cardresearch - Cardiologia Assistencial e Pesquisa
Belo Horizonte , Minas Gerais
NOT_YET_RECRUITING
UNESP - Faculdade de Medicina da Universidade Estadual Paulista
Botucatu , SÃO PAUL
NOT_YET_RECRUITING
L2IP - Instituto de Pesquisas Clínicas
Brasília , Federal District
NOT_YET_RECRUITING
L2IP - Instituto de Pesquisas Clínicas
Brasília , Federal District
NOT_YET_RECRUITING
Instituto de Pesquisa clinica de Campinas
Campinas , São Paulo
NOT_YET_RECRUITING
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre , Rio Grande do Sul
NOT_YET_RECRUITING
CoraCentro Pesquisa Clinica
Porto Alegre , Rio Grande do Sul
NOT_YET_RECRUITING
Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping
Ribeirão Preto , São Paulo
NOT_YET_RECRUITING
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto , São Paulo
NOT_YET_RECRUITING
CEPIC - Centro Paulista de Investigação Clínica
São Paulo
NOT_YET_RECRUITING
Incor - Instituto do Coracao
São Paulo
NOT_YET_RECRUITING
Bulgaria (13)
"Multiprofile Hospital for Active Treatment Puls" AD
Blagoevgrad
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
Gabrovo
Medical Center Hera - Kyustendil EOOD
Kyustendil
Diagnostic Consultative Center - 1 Lom EOOD
Lom , Montana
MHAT - Heart and Brain
Pleven
ACTIVE_NOT_RECRUITING
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv
MHAT Hadzhi Dimitar
Sliven
Diagnostic Consultative Center "Ascendent"
Sofia , Sofia (stolitsa)
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia , Sofia (stolitsa)
Diagnostic Consultative Center Aleksandrovska
Sofia , Sofia (stolitsa)
University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD
Sofia , Sofia (stolitsa)
Аcibadem City Clinic University MHAT EOOD - Third Clinical Base
Sofia
Medical Center Hera EOOD
Sofia
Canada (14)
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi , Quebec
Health Sciences North Research Institute
Greater Sudbury , Ontario
NOT_YET_RECRUITING
ACV Clinic
Greater Sudbury , Ontario
NOT_YET_RECRUITING
QEII Health Sciences Centre - Victoria General Site
Halifax , Nova Scotia
NOT_YET_RECRUITING
CHU de Quebec - Université Laval - Hotel Dieu de Quebec
Québec , Quebec
Richmond Clinical Trials
Richmond , British Columbia
CardioQuest Research Centre
Sarnia , Ontario
NOT_YET_RECRUITING
Clinique de Médecins Spécialistes
Shebrooke , Quebec
Diex Recherche Sherbrooke Est
Sherbrooke , Quebec
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
Terrebonne , Quebec
Corcare
Toronto , Ontario
NOT_YET_RECRUITING
Diex Recherche Trois-Rivieres
Trois-Rivières , Quebec
Community Care Building
Winchester , Ontario
Winchester District Memorial Hospital
Winchester , Ontario
China (7)
Peking University First Hospital
Beijing , Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha , Hunan
NOT_YET_RECRUITING
Guangdong Provincial People's Hospital
Guangzhou , Guangdong
NOT_YET_RECRUITING
Hainan General Hospital
Haikou , Hainan
NOT_YET_RECRUITING
The First Affiliated Hospital of University of South China
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