80 Participants Needed

Metformin for Heart Failure

(Met-PEF Trial)

Recruiting at 1 trial location
MB
Overseen ByMichael B Nelson
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
Prior Safety DataThis treatment has passed at least one previous human 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?

The research articles provided do not contain specific safety information about Metformin or its other names like Glucophage, Fortamet, Glumetza, or Riomet. They focus on other antidiabetic drugs and their effects on heart failure.12345

How does the drug Metformin differ from other treatments for heart failure?

Metformin is unique because it is primarily used to control blood sugar in type 2 diabetes, but it has shown potential benefits in heart failure patients by improving outcomes and reducing mortality, unlike some other diabetes drugs that may increase heart failure risk.15678

What data supports the effectiveness of the drug Metformin for heart failure?

Research indicates that Metformin, commonly used for diabetes, has shown improved outcomes in patients with both diabetes and heart failure, suggesting potential benefits for heart failure patients.158910

Who Is on the Research Team?

DW

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

My heart's left ventricle has mild dysfunction.
Final eligibility based on review of hospital and outpatient records, history, physical examination, echocardiogram, and familiarization/screening exercise test by a board-certified investigator cardiologist with extensive experience in heart failure investigations in older persons with HFpEF
I have heart failure with a normal heart pumping function.
See 5 more

Exclusion Criteria

Plans to leave area within 1 year
Your body mass index (BMI) is less than 25.0.
Your hemoglobin level is less than 9.5 grams.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive metformin or placebo for 20 weeks, with dose escalation over the first 3 weeks

20 weeks
1 visit (in-person) at week 4, bi-weekly virtual assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) at week 20

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin
  • Placebo
Trial Overview The Met-PEF study tests if taking metformin (1500 mg/day) for 20 weeks improves physical function, quality of life, gut health and reduces inflammation in older patients with HFpEF. It's a blind test where half the participants will get metformin and half will get a fake pill without knowing which one they're taking.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: MetforminActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Glucophage for:
🇺🇸
Approved in United States as Glucophage for:
🇨🇦
Approved in Canada as Glucophage for:
🇯🇵
Approved in Japan as Glucophage for:
🇨🇳
Approved in China as Glucophage for:
🇨🇭
Approved in Switzerland as Glucophage for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

University of South Florida

Collaborator

Trials
433
Recruited
198,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Newer diabetes medications, such as DPP-4 inhibitors, GLP-1 agonists, and SGLT-2 inhibitors, are being studied for their potential benefits in patients with heart failure, a condition that affects 25-35% of those with type 2 diabetes.
These drug classes are not only being evaluated for cardiovascular safety but also for their impact on heart function, quality of life, and progression of heart disease.
Treating Diabetes in Patients with Heart Failure: Moving from Risk to Benefit.DeFilippis, EM., Givertz, MM.[2019]
DPP-4 inhibitors and GLP-1 receptor agonists can significantly improve exercise tolerance in heart failure patients, as shown in a systematic review of four trials involving 659 patients.
These medications do not negatively impact quality of life or increase the risk of serious adverse events or mortality, suggesting they may be a safe option for heart failure patients, especially those with type 2 diabetes.
Targeting the DPP-4-GLP-1 pathway improves exercise tolerance in heart failure patients: a systematic review and meta-analysis.Chen, C., Huang, Y., Zeng, Y., et al.[2023]
There is a significant gap in the use of life-saving therapies for patients with heart failure with reduced ejection fraction, despite clear evidence that guideline-directed medical therapy (GDMT) and comprehensive disease-modifying medical therapy (CDMMT) improve patient outcomes.
Newer therapies, such as angiotensin receptor-neprilysin inhibitors and sodium-glucose cotransporter 2 inhibitors, show promise in enhancing efficacy and safety for heart failure treatment, yet their optimal use is not being fully realized globally.
The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction.Brownell, NK., Ziaeian, B., Fonarow, GC.[2021]

Citations

Treating Diabetes in Patients with Heart Failure: Moving from Risk to Benefit. [2019]
Targeting the DPP-4-GLP-1 pathway improves exercise tolerance in heart failure patients: a systematic review and meta-analysis. [2023]
The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. [2021]
Wrongfully accused: metformin use in heart failure. [2011]
The effects of antidiabetic agents on heart failure. [2022]
Incretin-Based Therapy for Diabetes: What a Cardiologist Needs to Know. [2018]
Dipeptidyl peptidase-4 inhibitors and heart failure: Analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System. [2017]
A Multicenter Observational Study of Incretin-based Drugs and Heart Failure. [2022]
Incretin-related drug therapy in heart failure. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Cardiovascular safety of dipeptidyl peptidase-4 inhibitors: recent evidence on heart failure. [2020]
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