A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Low Dose PF-07328948, Medium Dose PF-07328948, High Dose PF-07328948.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Bulgaria, Canada, China +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
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).
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.
Interventions
- Drug Placebo
ARM 1 - Drug Low Dose PF-07328948
ARM 2 - Drug Medium Dose PF-07328948
ARM 3 - Drug High Dose PF-07328948
ARM 4
Primary outcome measures
- Number of Participants with Clinical Events [Time frame: over 36 weeks]
- Change From Baseline in 6-Minute Walk Test (6MWD) [Time frame: Baseline, week 36 post-dose]
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) [Time frame: Baseline, week 36]
Secondary outcome measures (6)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [Time frame: Baseline, up to week 40]
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Symptom Score (KCCQ-23 TSS) and physical limitation in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF. [Time frame: Baseline, week 36]
- Change From Baseline in 6-minute walk test distance (6MWD) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF. [Time frame: Baseline, week 36]
- CPET Substudy) : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36 [Time frame: Baseline, Week 36]
- Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36 [Time frame: Baseline, Week 36]
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall clinical symptom Score (KCCQ-23 CSS) and physical limitation) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF. [Time frame: Baseline, week 36]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 28 centers
- National Heart Institute — Beverly Hills
- Orange County Research Center — Lake Forest
- Comprehensive Cardiovascular Care — Santa Maria
- FOMAT Medical Research — Santa Maria
- FWD Clinical Research — Boca Raton
- Jacksonville Center for Clinical Research — Jacksonville
- Infinite Clinical Research — Miami
- Flourish Research Acquisition, LLC dba Flourish Research - North Miami — Miami
- … and 20 more centers
Japan · 20 centers
Center list to be confirmed — check the primary protocol.
Canada · 14 centers
- Richmond Clinical Trials — Richmond
- QEII Health Sciences Centre - Victoria General Site — Halifax
- Health Sciences North Research Institute — Greater Sudbury
- ACV Clinic — Greater Sudbury
- CardioQuest Research Centre — Sarnia
- Corcare — Toronto
- Community Care Building — Winchester
- Winchester District Memorial Hospital — Winchester
- … and 6 more centers
Bulgaria · 13 centers
- Diagnostic Consultative Center - 1 Lom EOOD — Lom
- Diagnostic Consultative Center "Ascendent" — Sofia
- Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD — Sofia
- Diagnostic Consultative Center Aleksandrovska — Sofia
- University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD — Sofia
- "Multiprofile Hospital for Active Treatment Puls" AD — Blagoevgrad
- Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD — Gabrovo
- Medical Center Hera - Kyustendil EOOD — Kyustendil
- … and 5 more centers
China · 13 centers
- Peking University First Hospital — Beijing
- Lanzhou university second hospital — Lanzhou
- Guangdong Provincial People's Hospital — Guangzhou
- Hainan General Hospital — Haikou
- The First Hospital of Hebei Medical University — Shijiazhuang
- The Second Xiangya Hospital of Central South University — Changsha
- China-Japan Union Hospital — Changchun
- Shaanxi provincial people's hospital — Xi'an
- … and 5 more centers
Brazil · 11 centers
- L2IP - Instituto de Pesquisas Clínicas — Brasília
- L2IP - Instituto de Pesquisas Clínicas — Brasília
- Cardresearch - Cardiologia Assistencial e Pesquisa — Belo Horizonte
- Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre
- CoraCentro Pesquisa Clinica — Porto Alegre
- Instituto de Pesquisa clinica de Campinas — Campinas
- Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShoppin — Ribeirão Preto
- Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto
- … and 3 more centers
Spain · 11 centers
Center list to be confirmed — check the primary protocol.
Hungary · 8 centers
Center list to be confirmed — check the primary protocol.
Czechia · 7 centers
- Sdružené Zdravotnické Zařízení Krnov — Krnov
- … and 6 more centers
Poland · 6 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 6 centers
Center list to be confirmed — check the primary protocol.
France · 4 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06991257 · C4921003 · 2024-518438-94-00