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.