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Anti-diabetic drug

Metformin for Heart Failure (Met-PEF Trial)

Phase 2

Recruiting

Led By Dalane W. Kitzman, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Left ventricular diastolic dysfunction > grade 1 (American Society of Echocardiography Recommendations)

Heart failure with preserved ejection fraction (HFpEF) as defined by the American College of Cardiology/American Heart Association 2013 guidelines

Must not have

Significant renal insufficiency (estimated glomerular filtration rate [eGFR] <45 ml/min/1.73 m2)

Known valvular heart disease, infiltrative cardiomyopathy, or hypertrophic obstructive cardiomyopathy with active obstruction as the primary etiology of HF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 20

Summary

This trial will study the effects of metformin on heart failure patients with preserved ejection fraction.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Metformin can cause side effects like stomach upset including diarrhea, nausea and gas; vitamin B12 deficiency; lactic acid buildup in the blood which is rare but serious; muscle pain; low blood sugar levels especially when combined with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's left ventricle has mild dysfunction.

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I have heart failure with a normal heart pumping function.

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My heart pumps blood well, with an ejection fraction of 50% or higher.

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I am 60 years old or older.

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My symptoms are not caused by heart, lung, or other serious health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is significantly reduced.

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My heart failure is mainly due to a specific heart valve disease or thickened heart muscle.

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I am currently undergoing or have recently completed cancer treatment.

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I have been treated for diabetes with metformin or another drug.

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I do not have any health issues that would stop me from joining the study.

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I haven't used antibiotics, had diarrhea/vomiting, gut surgery recently, or have bowel issues.

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I have type 2 diabetes or my HbA1c level is above 6.5.

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I have severe long-term lung problems.

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I am not pregnant and can become pregnant.

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I have an irregular heartbeat that isn't well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak VO2

Other study objectives

6-minute walk distance (6MWD)

C-reactive protein

Fecal Mucin

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MetforminActive Control1 Intervention

20 weeks of metformin 1500 mg daily. Metformin is a widely used medication with an excellent safety profile. Dosing will be escalated during the first 3 weeks of treatment. Dosing will be initiated with 500 mg taken orally once daily in the evening for 1 week. After one week, the participant will be called to assess tolerance and will be asked to increase dose to two capsules per day for a total 1000 mg per day for one week. At the end of the second week, participants will be called again and if they tolerated the increased dose will be instructed to increase to three capsules (1500 mg/day) per day for the remainder of the 20 weeks. An extended release formulation will be used which improves compliance and reduces GI side effects.

Group II: PlaceboPlacebo Group1 Intervention

20 weeks of placebo 1500 mg daily. Placebo is a biologically inert substance placed in capsules to match appearance of active intervention (metformin). Dosing will be escalated during the first 3 weeks of treatment. Dosing will be initiated with 500 mg taken orally once daily in the evening for 1 week. After one week, the participant will be called to assess tolerance and will be asked to increase dose to two capsules per day for a total 1000 mg per day for one week. At the end of the second week, participants will be called again and if they tolerated the increased dose will be instructed to increase to three capsules (1500 mg/day) per day for the remainder of the 20 weeks.

0 / 15Eligibility criteria met