METFORMIN FOR ATRIAL FIBRILLATION (MAFT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05878535 |
Recruitment Status :
Not yet recruiting
First Posted : May 26, 2023
Last Update Posted : January 22, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Drug: Metformin Drug: Placebo | Phase 2 |
![Show](/ct2/html/images/expand.png)
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 770 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy And Safety Of Metformin For The Treatment Of Atrial Fibrillation |
Estimated Study Start Date : | June 1, 2024 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | April 2025 |
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
Arm | Intervention/treatment |
---|---|
Active Comparator: The Metformin Group (MG)
The group (n=385) will receive metformin oral tablets in addition to the standard rate/rhythm control strategy and anticoagulation. • Drug: 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. Other Name: Glucophage. |
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.
Other Name: Glucophage, Glumetza, and Riomet. |
Placebo Comparator: The Placebo Control Group (PCG)
The group (n=385) will receive placebo oral tablets in addition to the standard rate/rhythm control strategy and anticoagulation. • Drug: Placebo oral tablets. Prescribed: Once daily PO with meals and 200 mL of water. Other Name: Placebo |
Drug: Placebo
Placebo oral tablets. Prescribed: Once daily PO with meals and 200 mL of water. |
- Primary Endpoint [ Time Frame: 12 months since randomization ]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).
- Secondary Endpoint [ Time Frame: 12 months since randomization ]
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.
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05878535
Contact: Eslam Abbas, MBBCh, MSC | +201023054574 | islam.omr@med.au.edu.eg |
Egypt | |
Arab Contractors Medical Centre | |
Cairo, Egypt | |
Contact: Medical Research Office +20223426000 info@ac-medicalcenter.com |
Principal Investigator: | Eslam Abbas, MBBCh, MSC | Arab Contractors Medical Centre, and Dar El Salam Cancer Center |
Responsible Party: | Eslam Abbas, MBChB, MSc, Principal Invstigator, Arab Contractors Medical Centre |
ClinicalTrials.gov Identifier: | NCT05878535 |
Other Study ID Numbers: |
#18101829 |
First Posted: | May 26, 2023 Key Record Dates |
Last Update Posted: | January 22, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data can be shared with researchers who submit a proposal with a valuable research question as assessed by the clinical research office of Al-Azhar University. Requests should be directed to the corresponding authors. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | Data that underlie the results reported in this study will be available upon publication. |
Access Criteria: | Data can be shared with researchers who submit a proposal with a valuable research question. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Atrial Fibrillation, metformin, MACE. |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Metformin Hypoglycemic Agents Physiological Effects of Drugs |