RightFit
RecruitingPhase 2

A Study to Learn About the Study Medicine Called PF-07328948 in 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits, 10 visits
  • Time periods mentioned: 36 weeks, 48 weeks
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants will be involved in this study for about 48 weeks."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of PF-07328948 as a possible treatment for heart failure. It is for adults ages 18 to 79 who have had heart failure for at least 3 months.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 79 years old.
  • A doctor has confirmed that you have had heart failure for at least 3 months.
  • You have heart failure symptoms rated Class II to IV, meaning symptoms limit activity or happen at rest.
  • Your heart’s main pumping chamber pumps out more than 40% of its blood with each beat.
  • Your symptom score on the Kansas City Cardiomyopathy Questionnaire-23 is below 85.
  • You can walk more than 75 meters in 6 minutes.

Who can't join

  • You have type 1 diabetes, liver cirrhosis (scarring of the liver), or a condition that may affect how your body absorbs medicine.
  • You have major surgery planned during the study that the study doctor thinks would affect your walking.
  • You have had a heart transplant or are on a heart transplant waiting list.
  • You have plans to use medicines through a vein that widen blood vessels or help the heart pump harder.
  • You have had an allergy or could not tolerate an SGLT2 inhibitor, a type of medicine, or have a medical reason you cannot take one.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (28)

CA

FL

IL

IN

MD

NE

OH

TX