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NCT Number: NCT06991257

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

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).

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

L2IP - Instituto de Pesquisas Clínicas, Brasília, Federal District, Brazil

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About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

ARM 1

Low Dose PF-07328948

Drug

ARM 2

Other names: low dose

Medium Dose PF-07328948

Drug

ARM 3

Other names: medium dose

High Dose PF-07328948

Drug

ARM 4

Other names: High dose

Primary outcomes

  1. Number of Participants with Clinical Events

    Time frame: over 36 weeks

    Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.

  2. Change From Baseline in 6-Minute Walk Test (6MWD)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: Baseline, Week 36

    Cardiopulmonary exercise testing

  5. Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36

    Time frame: 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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 27, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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