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METFORMIN FOR ATRIAL FIBRILLATION

NCT05878535 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2024-01-22

No results posted yet for this study

Summary

The aim of this multicenter, pragmatic, open-label, randomized, placebo-controlled clinical trial is to test whether repurposing metformin for the treatment of atrial fibrillation will be effective in decreasing patients' hospitalization, adverse major cardiovascular events, and non-cancer death.

Participants will be randomized into 2 study arms (385 participant each), whereby:

* The Metformin Group (MG): will receive metformin oral tablets in addition to the standard rate/rhythm control strategy and anticoagulation.
* The Placebo Control Group (PCG): will receive placebo oral tablets as a control group in addition to the standard rate/rhythm control strategy and anticoagulation.

Then both arms will be compared according to the these endpoints:

* The primary endpoint is hospitalization due to an episodic AF or an AF with a rapid or slow ventricular response (in the case of permanent AF).
* The secondary endpoint is a composite of non-fatal major cardiovascular adverse events or non-cancer death.

The non-fatal major cardiovascular adverse events include:

* Hospitalization due to heart failure.
* Non-fatal myocardial infarction.
* Non-fatal stroke.
* Hospitalization due to unstable angina.

Conditions

Interventions

DRUG

Metformin

Metformin 850 mg oral tablets. Prescribed: Once daily PO with meals and 200 mL of water. The dose can be up-titrated to 1500-2000 mg divided q8-12hr with meals in enrolled diabetic patients as a monotherapy or combined with sulfonylurea.

DRUG

Placebo

Placebo oral tablets. Prescribed: Once daily PO with meals and 200 mL of water.

Sponsors & Collaborators

  • Arab Contractors Medical Centre

    lead OTHER

Principal Investigators

  • Eslam Abbas, MBBCh, MSC · Arab Contractors Medical Centre, and Dar El Salam Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-01-31
Completion
2025-04-30

Countries

  • Egypt

Study Locations

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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 NCT05878535 on ClinicalTrials.gov