> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-study-medicine-called-pf-07328948-4b8433c2-8478-4d23-8cfd-904517793566 > Record changed: 2026-10-13 # A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF) NCT06991257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) Participants 620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) Start date 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) Number of sites 142 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Short title** A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Dates **Completion date** 2027-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **First posted** 2025-05-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Registry last updated** 2026-05-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Primary completion date** 2027-11-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Start date** 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Size and sites **Participants** 620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Planned participants** 620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Number of sites** 142 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Identifiers **Registry ID** NCT06991257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **ClinicalTrials.gov ID** NCT06991257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-blind, placebo-controlled study **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Outcomes ### Primary outcomes 1. Number of Participants with Clinical Events Timeframe: over 36 weeks Adjudicated cardiovascular death and worsening heart failure events through 36 weeks. 2. Change From Baseline in 6-Minute Walk Test (6MWD) Timeframe: 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. 3. Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) Timeframe: 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. ### Secondary outcomes 1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Timeframe: Baseline, up to week 40 An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE that, at any dose, results in 1 or more of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events. 2. 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. Timeframe: Baseline, week 36 KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores are also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, Social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status. 3. 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. Timeframe: Baseline, week 36 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. 4. CPET Substudy) : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36 Timeframe: Baseline, Week 36 Cardiopulmonary exercise testing 5. Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36 Timeframe: Baseline, Week 36 NT-proBNP is a biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress). 6. 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. Timeframe: Baseline, week 36 KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores are also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 79 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Sites - National Heart InstituteBeverly Hills, United StatesRecruiting - Orange County Research CenterLake Forest, United StatesRecruiting - Comprehensive Cardiovascular CareSanta Maria, United StatesRecruiting - FOMAT Medical ResearchSanta Maria, United StatesRecruiting - FWD Clinical ResearchBoca Raton, United StatesActive, not recruiting - Jacksonville Center for Clinical ResearchJacksonville, United StatesRecruiting - Infinite Clinical ResearchMiami, United StatesRecruiting - Flourish Research Acquisition, LLC dba Flourish Research - North MiamiMiami, United StatesRecruiting - Amavita Research ServicesNorth Miami Beach, United StatesRecruiting - Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesRecruiting - NMH Clinical Research UnitChicago, United StatesRecruiting - Northwestern Memorial HealthCare - Arkes PavilionChicago, United StatesRecruiting - Northwestern Memorial HealthCare - Feinberg PavilionChicago, United StatesRecruiting - Northwestern Memorial HealthCare - Galter PavilionChicago, United StatesRecruiting - Northwestern Memorial Hospital Investigational Drug Service (IDS)Chicago, United StatesRecruiting - Northwestern UniversityEvanston, United StatesRecruiting - Chicago Medical ResearchHazel Crest, United StatesRecruiting - NexGen ResearchFort Wayne, United StatesRecruiting - Reid Physician AssociatesRichmond, United StatesRecruiting - Ascension Saint Agnes Heart CareBaltimore, United StatesRecruiting - Chesapeake Cardiac CareBowie, United StatesNot yet recruiting - Flourish Research - BowieBowie, United StatesNot yet recruiting - Velocity Clinical Research, Lincoln, Pioneer Heart InstituteLincoln, United StatesRecruiting - NexGen ResearchLima, United StatesRecruiting - Headlands Horizons, LLC dba Headlands Research-BrownsvilleBrownsville, United StatesRecruiting And 117 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4921003) ### Other registry identifiers - 2024-518438-94-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06991257) ## Related records ### Drugs (3) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) - [Samidorphan](https://trialight.com/data/asset/samidorphan-28d3f2c3-edbf-4d9b-a8ba-b5d5187b5cf9.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (1) - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Primary condition ### Targets (6) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [OPRD1](https://trialight.com/data/target/oprd1-5ce8b0d6-c823-51ce-a7b3-812976633078.md) - [OPRK1](https://trialight.com/data/target/oprk1-7b0a0fa0-a4b4-537b-bd00-d871256424e5.md) - [OPRM1](https://trialight.com/data/target/oprm1-04284660-78ba-5225-a86d-21f8a7325d8f.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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