Could a common diabetes drug help older heart failure patients move better?
NCT ID NCT05093959
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether metformin, a standard diabetes drug, could help older adults with a specific type of heart failure (HFpEF) feel better and move more easily. Over 20 weeks, 86 participants took either metformin or a placebo. Researchers measured exercise capacity, quality of life, and markers of inflammation and gut health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin
- What this could lead to
- If it works, this could point toward a simple, affordable treatment to improve exercise ability and daily life for older adults with this type of heart failure.
- What could go wrong
- This is a small, early-phase trial with only 86 participants, so results may not apply to everyone. Metformin can cause gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
86 people
The number who actually took part.
- Started
-
Jan 2022
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Heart failure with preserved ejection fraction (HFpEF) will be defined in accord with the American College of Cardiology/American Heart Association 2013 guidelines statement on Management of heart failure and as previously described. The 4 key inclusion criteria for HFpEF include: 1) clinical signs and symptoms as scored by National Health and Nutrition Examination Survey (NHANES)-HF Clinical Score ≥3 and the Rich Criteria; 2) a normal left ventricular (LV) ejection fraction (≥50%) by echocardiography; 3) LV diastolic dysfunction \> grade 1 (American Society of Echocardiography Recommendations); 4) no evidence of significant ischemic, valvular, pulmonary or other medical disorder to account for their symptoms. * Age ≥60 * Stable HF symptoms and medications for ≥3 weeks * Final eligibility will be based upon all information available at the conclusion of the baseline visits tests, including review of hospital and outpatient records, history, physical examination, echocardiogram, and familiarization/screening exercise test by a board-certified investigator cardiologist who have extensive experience in heart failure investigations in older persons with HFpEF Exclusion Criteria: * History of treatment with metformin or other anti-diabetic drug intended to treat diabetes * Body mass index (BMI) \<25.0 * Uncontrolled dysrhythmia * Uncontrolled hypertension (systolic blood pressure \[SPB\]\>200 mmHg or diastolic blood pressure \[DBP\]\>100 mmHg at rest) * Significant anemia (\<9.5 g hemoglobin \[Hb\]) (eligibility will be determined by complete blood count) * Significant renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<45 ml/min/1.73 m2) (eligibility will be determined by comprehensive metabolic panel) * Acute or chronic metabolic acidosis * Type 2 diabetes, or HbA1c\>6.5 * Low vitamin B12 (\<232 pg/mL) * Known valvular heart disease, infiltrative cardiomyopathy, or hypertrophic obstructive cardiomyopathy with active obstruction as the primary etiology of HF * Evidence of significant chronic obstructive pulmonary disease (COPD) defined as either: a. On continuous home oxygen therapy for COPD; b. Hospitalization for COPD in last 6 months * Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc. * Alcohol abuse (\>14 drinks/week) * Current or recent cancer, or chemotherapy/radiation treatment * Pregnancy-women of child-bearing potential are excluded from participation in this study. * A treadmill exercise test revealing: a. Evidence of significant ischemia; b. Electrocardiogram: 1mm flat ST depression; c. Stopped exercising due to chest or leg claudication or any reason other than exhaustion/fatigue/dyspnea; d. Exercise SBP \> 240 mmHg, DBP \> 110 mmHg ; e. Unstable hemodynamics or rhythm; f. Unwilling or unable to complete adequate exercise test * Exclusions for microbiome testing: a. Antibiotics use within last 30 days; b. Diarrhea and/or vomiting within last 30 days; c. Surgery related to gut in last 6 months; d. Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or irritable bowel syndrome * Plans to leave area within 1 year * Currently participating in other investigational study * Refuses informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atrium Health Sanger Heart and Vascular Clinic Institute
Charlotte, North Carolina, 28203, United States
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Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
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