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NCT05093959 · ClinicalTrials.gov registry record · Phase 2

Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction

A Phase 2 study of Heart Failure With Preserved Ejection Fraction, sponsored by Wake Forest University Health Sciences.

Active
Registry status
Phase 2
Development phase
86
Enrollment target
2
Study locations

NCT05093959: Active Phase 2 study of Heart Failure With Preserved Ejection Fraction, sponsored by Wake Forest University Health Sciences.

NCT05093959 is a Phase 2 study of Heart Failure With Preserved Ejection Fraction that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 86 participants, below the 2,286-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05093959, a Phase 2 study of Heart Failure With Preserved Ejection Fraction, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
86 participants
Enrollment target
2
Study locations

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).

Primary Outcome

Peak VO2 (ml of O2 relative to kg of body weight per minute \[ml/kg/min\]) is a measure of peak oxygen capacity during exercise, is a standardized, objective, reproducible and valid measure of exercise capacity.

Interventions

  • DRUG Placebo
  • DRUG Metformin

Study Locations (2)

North Carolina

  • Atrium Health Sanger Heart and Vascular Clinic Institute - Charlotte
  • Wake Forest School of Medicine - Winston-Salem

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2022-01-04
Est. Completion 2026-04
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the registry record for NCT05093959 still lists

NCT05093959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 2,286-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05093959 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT05093959 about?

NCT05093959 is a clinical study titled "Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction". 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 prese...

What is the current status of trial NCT05093959?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2022-01-04. Estimated completion is 2026-04.

What conditions does trial NCT05093959 study?

This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction.

What interventions are being tested in trial NCT05093959?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).

Who is sponsoring clinical trial NCT05093959?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05093959 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Heart Failure With Preserved Ejection Fraction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05093959's enrollment target sits among peer trials

86 20th of 42 higher than 23 of 42 other Heart Failure With Preserved Ejection Fraction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure With Preserved Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05093959, the US trial registry maintained by the National Library of Medicine. NCT05093959 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.