METFORMIN FOR ATRIAL FIBRILLATION

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arab Contractors Medical Centre
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent prior to performing study procedures.

• Atrial fibrillation (first detected, paroxysmal, persistent, longstanding persistent, or permanent)*.

• Types of atrial fibrillation:

• First detected: only one diagnosed episode.

• Paroxysmal: recurrent episodes that stop on their own in less than seven days.

• Persistent: recurrent episodes that last more than seven days.

• Longstanding persistent: recurrent episodes that last more than twelve months.

• Permanent: atrial fibrillation that has been accepted, and for which a solely rate control strategy has been decided upon.

Exclusion Criteria:

• Critically-ill patients who are admitted to ICU.

• Advanced congestive heart failure.

• Liver cell failure.

• Chronic kidney disease with eGFR <45 mL/min/1.73 m².

• Diabetic ketoacidosis with or without coma.

• Concomitant treatment with carbonic anhydrase inhibitors.

• Septicemia.

• Shock.

• Hypoxia.

• Dehydration.

• Blood Dyscrasias.

• Alcoholism.

• Pregnancy.

• Lactation.

• Chronic muscle diseases.

• Acute trauma or burns within 2 weeks.

• History of allergy to the implemented drugs.