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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 20
Awards & highlights
Met-PEF Trial 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.Check my eligibility
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.See study design
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.
Met-PEF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's left ventricle has mild dysfunction.
Select...
I have heart failure with a normal heart pumping function.
Select...
My heart pumps blood well, with an ejection fraction of 50% or higher.
Select...
I am 60 years old or older.
Select...
My symptoms are not caused by heart, lung, or other serious health issues.
Met-PEF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak VO2
Other outcome measures
6-minute walk distance (6MWD)
C-reactive protein
Fecal Mucin
+5 moreMet-PEF 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.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,187 Total Patients Enrolled
8 Trials studying Heart Failure
2,948 Patients Enrolled for Heart Failure
University of South FloridaOTHER
411 Previous Clinical Trials
186,949 Total Patients Enrolled
1 Trials studying Heart Failure
28 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,583 Total Patients Enrolled
42 Trials studying Heart Failure
213,235 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's left ventricle has mild dysfunction.Your body mass index (BMI) is less than 25.0.Your hemoglobin level is less than 9.5 grams.You drink more than 14 alcoholic drinks per week.You have a condition with too much acid in your body.My kidney function is significantly reduced.I have heart failure with a normal heart pumping function.My heart failure is mainly due to a specific heart valve disease or thickened heart muscle.I am currently undergoing or have recently completed cancer treatment.My heart failure symptoms and medications have been stable for at least 3 weeks.My heart pumps blood well, with an ejection fraction of 50% or higher.I am 60 years old or older.I have been treated for diabetes with metformin or another drug.I do not have any health issues that would stop me from joining the study.I haven't used antibiotics, had diarrhea/vomiting, gut surgery recently, or have bowel issues.I have type 2 diabetes or my HbA1c level is above 6.5.I have severe long-term lung problems.Your blood pressure is very high and not under control.My symptoms are not caused by heart, lung, or other serious health issues.You had a treadmill test that showed signs of heart problems, such as specific changes on the heart monitor, high blood pressure during exercise, or unstable heart rhythm.You have certain symptoms and signs related to heart failure.I am not pregnant and can become pregnant.I have an irregular heartbeat that isn't well-managed.Your vitamin B12 levels are lower than 232 pg/mL.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Metformin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary reason that Metformin is prescribed?
"Metformin is frequently used to help people with type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome by regulating their blood sugar levels."
Answered by AI
Are we still enrolling individuals for this research project?
"Yes, the information on clinicaltrials.gov indicates that this trial is looking for patients. The trial was first posted on 1/4/2022 and most recently edited on 9/28/2022. The study is searching for 80 patients across 2 sites"
Answered by AI
What is the sample size for this experiment?
"That is correct. The clinicaltrials.gov website lists this study as currently open for recruitment. This trial was originally posted on January 4th, 2022 and was last updated on September 28th, 2022. 80 patients are needed at 2 locations."
Answered by AI
What is the historical precedent for Metformin in clinical trials?
"As of the most recent data, there are a total of 179 studies involving metformin. 44 of those trials are currently in phase 3. Although many of the trials for metformin originate in Rockville, Maryland, there are 1951 locations across the globe running these types of studies."
Answered by AI
What is the Metformin FDA status?
"Metformin's safety is rated at a 2 because, although there is some evidence backing its safety, Phase 2 trials have not shown any efficacy."
Answered by AI
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