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

NCT06991257 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2025-06-19

Last updated

2026-05-27

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

PlaceboLow Dose PF-07328948Medium Dose PF-07328948High Dose PF-07328948

Placebo: ARM 1

Low Dose PF-07328948: ARM 2

Medium Dose PF-07328948: ARM 3

High Dose PF-07328948: ARM 4

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

79 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of Participants with Clinical Events — over 36 weeks
Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
Change From Baseline in 6-Minute Walk Test (6MWD) — Baseline, week 36 post-dose
A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) — Baseline, week 36
KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.

Trial sites (142)

Facility	City	Region	Status
National Heart Institute	Beverly Hills	California	Recruiting
Orange County Research Center	Lake Forest	California	Recruiting
Comprehensive Cardiovascular Care	Santa Maria	California	Recruiting
FOMAT Medical Research	Santa Maria	California	Recruiting
FWD Clinical Research	Boca Raton	Florida	Active Not Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
Infinite Clinical Research	Miami	Florida	Recruiting
Flourish Research Acquisition, LLC dba Flourish Research - North Miami	Miami	Florida	Recruiting
Amavita Research Services	North Miami Beach	Florida	Recruiting
Clinical Site Partners, LLC dba Flourish Research	Winter Park	Florida	Recruiting
NMH Clinical Research Unit	Chicago	Illinois	Recruiting
Northwestern Memorial HealthCare - Arkes Pavilion	Chicago	Illinois	Recruiting
Northwestern Memorial HealthCare - Feinberg Pavilion	Chicago	Illinois	Recruiting
Northwestern Memorial HealthCare - Galter Pavilion	Chicago	Illinois	Recruiting
Northwestern Memorial Hospital Investigational Drug Service (IDS)	Chicago	Illinois	Recruiting
Northwestern University	Evanston	Illinois	Recruiting
Chicago Medical Research	Hazel Crest	Illinois	Recruiting
NexGen Research	Fort Wayne	Indiana	Recruiting
Reid Physician Associates	Richmond	Indiana	Recruiting
Ascension Saint Agnes Heart Care	Baltimore	Maryland	Recruiting
Chesapeake Cardiac Care	Bowie	Maryland	Not Yet Recruiting
Flourish Research - Bowie	Bowie	Maryland	Not Yet Recruiting
Velocity Clinical Research, Lincoln, Pioneer Heart Institute	Lincoln	Nebraska	Recruiting
NexGen Research	Lima	Ohio	Recruiting
Headlands Horizons, LLC dba Headlands Research-Brownsville	Brownsville	Texas	Recruiting
Valley Regional Medical Center	Brownsville	Texas	Recruiting
North Dallas Research Associates	McKinney	Texas	Recruiting
Northwest Houston Heart Center	Tomball	Texas	Recruiting
L2IP - Instituto de Pesquisas Clínicas	Brasília	Federal District	Recruiting
L2IP - Instituto de Pesquisas Clínicas	Brasília	Federal District	Recruiting
Cardresearch - Cardiologia Assistencial e Pesquisa	Belo Horizonte	Minas Gerais	Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande do Sul	Recruiting
CoraCentro Pesquisa Clinica	Porto Alegre	Rio Grande do Sul	Recruiting
Instituto de Pesquisa clinica de Campinas	Campinas	São Paulo	Recruiting
Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping	Ribeirão Preto	São Paulo	Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto	São José do Rio Preto	São Paulo	Recruiting
UNESP - Faculdade de Medicina da Universidade Estadual Paulista	Botucatu	SÃO PAUL	Recruiting
CEPIC - Centro Paulista de Investigação Clínica	São Paulo	Brazil	Recruiting
Incor - Instituto do Coracao	São Paulo	Brazil	Recruiting
Diagnostic Consultative Center - 1 Lom EOOD	Lom	Montana	Recruiting

+ 102 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06991257 on ClinicalTrials.gov ↗ ← All trials in the USA