Testing Low Dose PF-07328948 against a placebo for heart failure
Official title: 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)
Interventions
Placebo
ARM 1
Low Dose PF-07328948
ARM 2
Medium Dose PF-07328948
ARM 3
High Dose PF-07328948
ARM 4
Canadian Sites (14)
Richmond Clinical Trials
Richmond, British Columbia, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
ACV Clinic
Greater Sudbury, Ontario, Canada
CardioQuest Research Centre
Sarnia, Ontario, Canada
Corcare
Toronto, Ontario, Canada
Community Care Building
Winchester, Ontario, Canada
Winchester District Memorial Hospital
Winchester, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
CHU de Quebec - Université Laval - Hotel Dieu de Quebec
Québec, Quebec, Canada
Clinique de Médecins Spécialistes
Shebrooke, Quebec, Canada
Diex Recherche Sherbrooke Est
Sherbrooke, Quebec, Canada
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
Terrebonne, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor
- +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 CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → include:
- +Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
- +History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
- +Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
Exclusion
- −Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor
- −Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
- −History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
- −Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →, Low Dose PF-07328948, Medium Dose PF-07328948, High Dose PF-07328948.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 79 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 620 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: over 36 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of Participants with Clinical Events — measured over over 36 weeks.
Change From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in 6-Minute Walk Test (6MWD) — measured over Baseline, week 36 post-dose.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) — measured over Baseline, week 36.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06991257 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PlaceboDrug
ARM 1
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Low Dose PF-07328948Drug
ARM 2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Medium Dose PF-07328948Drug
ARM 3
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About High Dose PF-07328948Drug
ARM 4
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 79 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 79 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: over 36 weeks.
The study as a whole is currently expected to finish around 2027-12-14.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 620 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Richmond, British Columbia, Canada; Halifax, Nova Scotia, Canada; Greater Sudbury, Ontario, Canada; Sarnia, Ontario, Canada; Toronto, Ontario, Canada; Winchester, Ontario, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.