Metformin for Heart Failure
(Met-PEF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Met-PEF will be a randomized, double-blind, placebo-controlled trial to examine the effects of 20 weeks of 1500 mg/day of metformin on physical function, quality of life (QOL), microbiome diversity, leaky gut, and systemic inflammation in patients with 80 older patients with heart failure with preserved ejection fraction (HFpEF).
Will I have to stop taking my current medications?
The trial requires that your heart failure symptoms and medications have been stable for at least 3 weeks before joining. However, the protocol does not specify if you need to stop any current medications, so it's best to discuss this with the trial team.
Is Metformin safe for use in humans?
How does the drug Metformin differ from other treatments for heart failure?
Who Is on the Research Team?
Dalane W. Kitzman, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for people aged 60 or older with heart failure where the heart pumps normally (HFpEF). They must have stable symptoms and not be on metformin or other diabetes drugs, have a BMI of 25 or higher, normal blood pressure and kidney function, no significant anemia, acidosis, diabetes, severe lung disease, recent cancer treatments or certain heart conditions. Participants should not plan to move away within a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin or placebo for 20 weeks, with dose escalation over the first 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Metformin
- Placebo
Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
University of South Florida
Collaborator
National Institute on Aging (NIA)
Collaborator