Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Freedom from recurrent atrial arrhythmias by 12 months after a single ablation to eliminate AF
研究概览
简要总结
This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF). Atrial fibrillation is an abnormal heart rhythm which research has shown is related in part to obesity and diabetes.
It is anticipated that the participants treated in the metformin arm will have greater freedom from recurrent atrial arrhythmias after ablation.
Eligible participants enrolled in the trial will be assigned to one of the treatment arms (no treatment or metformin) and have follow-up visits up to approximately 1 year after the ablation. Additionally, all patients will also receive education on lifestyle changes and exercise which are standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation
- •All subjects must be able to understand and willing to sign a written informed consent document.
排除标准
- •Individuals who are already taking metformin or other antidiabetic medications, including insulin
- •Known diabetes
- •Known allergy or Food and Drug Administration (FDA)-labeled contraindication to taking metformin (estimated glomerular filtration rate (eGFR)<30 millilitres per minute (mL/min)/1.73 square meters (m2), hypersensitivity to metformin, acute or chronic metabolic acidosis)
- •Patients taking carbonic anhydrase inhibitors
- •eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease
- •Acute or chronic metabolic acidosis (serum bicarbonate <22 milliequivalents per liter (mEq/L))
- •History of significant alcohol use (>2 drinks/day on average)
- •History of hepatic dysfunction (serum bilirubin 1.5 times greater than ULN)
- •History of New York Heart Association (NYHA) Class III or IV heart failure
- •Pregnancy or nursing
研究组 & 干预措施
Metformin
Standard of care ablation with recommendations for lifestyle modification and metformin.
干预措施: Metformin (Drug)
Metformin
Standard of care ablation with recommendations for lifestyle modification and metformin.
干预措施: Recommendations for lifestyle modification. (Behavioral)
Metformin
Standard of care ablation with recommendations for lifestyle modification and metformin.
干预措施: AliveCor (Device)
Standard of care
Standard of care ablation with recommendations for lifestyle modification.
干预措施: Recommendations for lifestyle modification. (Behavioral)
Standard of care
Standard of care ablation with recommendations for lifestyle modification.
干预措施: AliveCor (Device)
结局指标
主要结局
Freedom from recurrent atrial arrhythmias by 12 months after a single ablation to eliminate AF
时间窗: 12 months after ablation
There will be a 3 month blanking period after ablation during which recurrent atrial arrhythmias will not contribute to the primary endpoint.
次要结局
- Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation(up to 1 year after after ablation)
- Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months(6 months after ablation)
- Percent change in weight at 6 months after ablation(6 months after ablation)
- Percent change in hemoglobin A1c at 6 months after ablation(6 months after ablation)
- Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation(6 months after a repeated ablation)
- Atrial Fibrillation Severity Score (AFSS)(up to 12 months after ablation)
- Percent change in weight at 3 months after ablation(3 months after ablation)
- Percent change in hemoglobin A1C at 12 months after ablation(12 months after ablation)
- Incidence of major procedural complications(up to 30 days)
- Atrial Fibrillation related morbidity during follow-up(up to approximately 1 year after ablation)
- Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices(3 months after ablation)
研究者
Hakan Oral
Professor of Internal Medicine
University of Michigan