NCT05093959

Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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 86 older patients with heart failure with preserved ejection fraction (HFpEF).

Detailed description

Enrollment of participants will be conducted at both Wake Forest and Atrium Health (approximately 43 participants at each site) following assessment of eligibility criteria and willingness to participate in the trial. Eligibility criteria are designed to target the population under study and exclude participants unable to safely take the study intervention or undergo study procedures. Informed consent will be obtained from qualified participants. Participants will complete baseline assessments before masked, random assignment to metformin or placebo. The assigned study medications will be dispensed by the research pharmacy. Participants will take assigned metformin or placebo for a treatment period of 20 weeks, starting at 500mg/day and escalating over the first 3 weeks to a target dose of 1500mg/day. Participants will be contacted every 2 weeks for assessment of adverse events, side effects, and adherence. At week 4, participants will be seen in clinic for safety laboratory assessments. At week 20, participants will complete follow-up assessments by an assessor blinded to treatment group.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	Metformin	An extended release formulation will be used which improves compliance and reduces GI side effects.
DRUG	Placebo	Placebo is a biologically inert substance placed in capsules to match appearance of active intervention

Timeline

• Start date: 2022-01-04
• Primary completion: 2025-12-18
• Completion: 2026-04-01
• First posted: 2021-10-26
• Last updated: 2026-01-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study