Atrial FibrillationPhase 2NCT02931253
Metformin as an Upstream Therapy in Atrial Fibrillation
A Phase 2 study testing Metformin in people with Atrial Fibrillation, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. This study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation. Metformin is investigational for use in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 10 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. All subjects must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. This study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation.
Metformin is investigational for use in patients with atrial fibrillation. Metformin is approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes Mellitus. Metformin is used with a proper diet and exercise program to control high blood sugar, and has been shown to help people lose weight. This study aims to look at the effects of metformin on weight loss and heart rhythm in patients with atrial fibrillation.
Read the detailed description
Enrollment: Consent, medical history, and dietary education. Randomization. treatment Metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. Pre procedure safety labs, EKG, Atrial Fibrillation Severity Score survey, metformin held 48 hours prior to rhythm control procedure. Treatment resumed 48 hours post procedure or when renal function at baseline. Treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. Follow-up at 3 month and 6 month post procedure. Continuation of treatment at study completion determined by primary cardiologist or care provider.
- Conditions
- Atrial Fibrillation
- Being tested
- Metformin
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group | Experimental | 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. Receives: Drug: Metformin |
| Control Group | No intervention | Standard of care - ablation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Maintain Sinus Rhythm
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
Measured: 6 months
Secondary outcomes (6)
Number of Participants Requiring Hospitalization
Hospitalization related to arrhythmic events or medication side effects
Measured: 6 months
Number of Participants Requiring Antiarrhythmic Medications
Total count of participants on anti-arrhythmic medications
Measured: 6 months
Number of Participants Requiring Repeat Ablations
Measured: 6 months
Change in BMI
Average change in BMI from baseline to 6 month.
Measured: Baseline to 6 months
Hemoglobin A1c
Change from baseline to 6 month
Measured: Baseline to 6 months
Number of Participants With Thromboembolic Events
Number of participants who have a thromboembolic event from baseline to 6 months
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start11 Apr 2017
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Why it stopped: Recruitment issue: Enrollment expectation not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931253
- Sponsor's protocol ID
- 1602-01
- Status last verified
- Mar 2023
- First submitted
- 7 Oct 2016
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin as an Upstream Therapy in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02931253
- Acronym / sponsor ID
- 1602-01
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issue: Enrollment expectation not met
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. This study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation.
Metformin is investigational for use in patients with atrial fibrillation. Metformin is approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes Mellitus. Metformin is used with a proper diet and exercise program to control high blood sugar, and has been shown to help people lose weight. This study aims to look at the effects of metformin on weight loss and heart rhythm in patients with atrial fibrillation.
Detailed description
Enrollment: Consent, medical history, and dietary education. Randomization. treatment Metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. Pre procedure safety labs, EKG, Atrial Fibrillation Severity Score survey, metformin held 48 hours prior to rhythm control procedure. Treatment resumed 48 hours post procedure or when renal function at baseline. Treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. Follow-up at 3 month and 6 month post procedure. Continuation of treatment at study completion determined by primary cardiologist or care provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Experimental | Drug: MetforminMetformin 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. |
| Control Group | No intervention | –Standard of care - ablation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. All subjects must be able to understand and willing to sign a written informed consent document.
Key exclusion criteria (1 listed)
- Individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 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. | Drug | Metformin Group |
Primary outcome
Number of Participants Who Maintain Sinus Rhythm
Time frame: 6 months
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
6 secondary outcomes
Number of Participants Requiring Hospitalization
Time frame: 6 months
Number of Participants Requiring Antiarrhythmic Medications
Time frame: 6 months
Number of Participants Requiring Repeat Ablations
Time frame: 6 months
Change in BMI
Time frame: Baseline to 6 months
Hemoglobin A1c
Time frame: Baseline to 6 months
Number of Participants With Thromboembolic Events
Time frame: from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Atrial Fibrillation, run by The Guthrie Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Maintain Sinus Rhythm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.