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Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction

NCT05093959 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-05-05

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • University of South Florida

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Dalane W. Kitzman, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2025-12-18
Completion
2026-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093959 on ClinicalTrials.gov