PF-07328948 for adults with heart failure (BRANCH-HF).
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN ORAL BRANCHED-CHAIN KETOACID DEHYDROGENASE KINASE INHIBITOR, PF-07328948, IN ADULTS WITH HEART FAILURE (BRANCH-HF)
This trial will test whether taking PF-07328948 once daily helps adults with heart failure who are already on standard medicines, including SGLT2 inhibitors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 620 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 139 sites (Beverly Hills, California and 138 other locations) |
| Trial ID | NCT06991257 on ClinicalTrials.gov |
What this trial studies
BRANCH-HF is a phase 2, randomized, placebo-controlled trial testing three dose levels of PF-07328948 versus placebo in adults with heart failure and left ventricular ejection fraction greater than 40%. Participants will take the study medicine or placebo once daily for 36 weeks while continuing standard-of-care treatment including SGLT2 inhibitors. The study follows participants for about 48 weeks with 15 visits total, roughly 10 in-person clinic visits and up to 5 remote contacts. Safety, tolerability, and effects on symptoms and functional capacity will be measured to help define optimal dosing.
Who should consider this trial
Good fit: Adults aged 18–79 with a clinical diagnosis of heart failure for at least 3 months, NYHA class II–IV, left ventricular ejection fraction >40%, and already taking SGLT2 inhibitors are the intended participants.
Not a fit: People with type 1 diabetes, liver cirrhosis, known intolerance or contraindication to SGLT2 inhibitors, those on IV inotropes or listed for transplant, or with conditions that affect drug absorption are unlikely to be eligible or receive benefit from this trial.
Why it matters
Potential benefit: If effective, PF-07328948 could reduce symptoms and improve exercise capacity for people with HFmrEF or HFpEF, providing a new oral treatment option.
How similar studies have performed: Some other heart-failure trials have shown benefit from SGLT2 inhibitors in HFpEF/HFmrEF, but PF-07328948 is a novel investigational medicine currently being tested in early-phase trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beverly Hills, California and 138 other locations
- National Heart Institute — Beverly Hills, California, United States (Recruiting)
- Orange County Research Center — Lake Forest, California, United States (Recruiting)
- Comprehensive Cardiovascular Care — Santa Maria, California, United States (Recruiting)
- FOMAT Medical Research — Santa Maria, California, United States (Recruiting)
- FWD Clinical Research — Boca Raton, Florida, United States (Active_not_recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- Infinite Clinical Research — Miami, Florida, United States (Recruiting)
- Flourish Research Acquisition, LLC dba Flourish Research - North Miami — Miami, Florida, United States (Recruiting)
- Amavita Research Services — North Miami Beach, Florida, United States (Recruiting)
- Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States (Recruiting)
- NMH Clinical Research Unit — Chicago, Illinois, United States (Recruiting)
- Northwestern Memorial HealthCare - Arkes Pavilion — Chicago, Illinois, United States (Recruiting)
- Northwestern Memorial HealthCare - Feinberg Pavilion — Chicago, Illinois, United States (Recruiting)
- Northwestern Memorial HealthCare - Galter Pavilion — Chicago, Illinois, United States (Recruiting)
- Northwestern Memorial Hospital Investigational Drug Service (IDS) — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Recruiting)
- Chicago Medical Research — Hazel Crest, Illinois, United States (Recruiting)
- NexGen Research — Fort Wayne, Indiana, United States (Recruiting)
- Reid Physician Associates — Richmond, Indiana, United States (Recruiting)
- Ascension Saint Agnes Heart Care — Baltimore, Maryland, United States (Recruiting)
- Chesapeake Cardiac Care — Bowie, Maryland, United States (Not_yet_recruiting)
- Flourish Research - Bowie — Bowie, Maryland, United States (Not_yet_recruiting)
- Velocity Clinical Research, Lincoln, Pioneer Heart Institute — Lincoln, Nebraska, United States (Recruiting)
- NexGen Research — Lima, Ohio, United States (Recruiting)
- Headlands Horizons, LLC dba Headlands Research-Brownsville — Brownsville, Texas, United States (Recruiting)
- Valley Regional Medical Center — Brownsville, Texas, United States (Recruiting)
- North Dallas Research Associates — McKinney, Texas, United States (Recruiting)
- Northwest Houston Heart Center — Tomball, Texas, United States (Recruiting)
- L2IP - Instituto de Pesquisas Clínicas — Brasília, Federal District, Brazil (Recruiting)
- L2IP - Instituto de Pesquisas Clínicas — Brasília, Federal District, Brazil (Recruiting)
- Cardresearch - Cardiologia Assistencial e Pesquisa — Belo Horizonte, Minas Gerais, Brazil (Not_yet_recruiting)
- Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil (Not_yet_recruiting)
- CoraCentro Pesquisa Clinica — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Instituto de Pesquisa clinica de Campinas — Campinas, São Paulo, Brazil (Recruiting)
- Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping — Ribeirão Preto, São Paulo, Brazil (Recruiting)
- Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto, São Paulo, Brazil (Not_yet_recruiting)
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista — Botucatu, São Paul, Brazil (Recruiting)
- CEPIC - Centro Paulista de Investigação Clínica — São Paulo, Brazil (Not_yet_recruiting)
- Incor - Instituto do Coracao — São Paulo, Brazil (Recruiting)
- Diagnostic Consultative Center - 1 Lom EOOD — Lom, Montana, Bulgaria (Recruiting)
- Diagnostic Consultative Center "Ascendent" — Sofia, Sofia (stolitsa), Bulgaria (Recruiting)
- Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD — Sofia, Sofia (stolitsa), Bulgaria (Recruiting)
- Diagnostic Consultative Center Aleksandrovska — Sofia, Sofia (stolitsa), Bulgaria (Recruiting)
- University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD — Sofia, Sofia (stolitsa), Bulgaria (Recruiting)
- "Multiprofile Hospital for Active Treatment Puls" AD — Blagoevgrad, Bulgaria (Recruiting)
- Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD — Gabrovo, Bulgaria (Recruiting)
- Medical Center Hera - Kyustendil EOOD — Kyustendil, Bulgaria (Recruiting)
- MHAT - Heart and Brain — Pleven, Bulgaria (Active_not_recruiting)
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD — Plovdiv, Bulgaria (Recruiting)
- MHAT Hadzhi Dimitar — Sliven, Bulgaria (Recruiting)
+89 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.