Trial Outcomes & Findings for Metformin as an Upstream Therapy in Atrial Fibrillation (NCT NCT02931253)

NCT ID: NCT02931253

Last Updated: 2024-01-25

Results Overview

Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-01-25

Participant Flow

Study terminated prior to meeting enrollment target. Enrollment rate slower than expected.

Participant milestones

Measure	Metformin Group Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group Standard of care - ablation only
Overall Study STARTED	2	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only	Total n=6 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 4 • n=2 Participants	65 years STANDARD_DEVIATION 3 • n=4 Participants	66 years STANDARD_DEVIATION 4 • n=6 Participants
Sex: Female, Male Female	0 Participants n=2 Participants	1 Participants n=4 Participants	1 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=2 Participants	3 Participants n=4 Participants	5 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	4 participants n=4 Participants	6 participants n=6 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Number of Participants Who Maintain Sinus Rhythm	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Hospitalization related to arrhythmic events or medication side effects

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Number of Participants Requiring Hospitalization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Total count of participants on anti-arrhythmic medications

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Number of Participants Requiring Antiarrhythmic Medications	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Number of Participants Requiring Repeat Ablations	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to 6 months

Average change in BMI from baseline to 6 month.

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Change in BMI	1.8 kg/m^2 Standard Deviation .8	1.7 kg/m^2 Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline to 6 months

Change from baseline to 6 month

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Hemoglobin A1c	.1 percent glycosylated hemoglobin Standard Deviation .14	.15 percent glycosylated hemoglobin Standard Deviation .1

SECONDARY outcome

Timeframe: from baseline to 6 months

Number of participants who have a thromboembolic event from baseline to 6 months

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Number of Participants With Thromboembolic Events	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

Weight change from baseline to 6 months.

Outcome measures

Measure	Metformin Group n=2 Participants Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks. Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.	Control Group n=4 Participants Standard of care - ablation only
Weight Loss	2 pounds Standard Deviation 6.3	-.6 pounds Standard Deviation 3.4

Adverse Events

Metformin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pramod Deshmukh, MD

The Donald Guthrie Foundation for Education and Research

Phone: 570 887 2284

Email: Pramod.Deshmukh@guthrie.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place