Efficacy of Cardiometabolic Risk Factor Control Through Metabolic Surgery on Management and Severity of Atrial Fibrillation: METSAFE Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relative change in total duration of being in atrial fibrillation (AF)
研究概览
简要总结
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is estimated that between 3 and 6 million Americans are currently living with AF, while 12 million people in the United States will have AF in 2030. Obesity and its comorbidities such as type 2 diabetes (T2DM), hypertension, and obstructive sleep apnea (OSA) are major risk factors for development and progression of AF. Metabolic and Bariatric Surgery (MBS) is the most effective currently available treatment for obesity. Patients typically lose 20 to 35 percent of body weight after surgery which is often sustained for many years. MBS can improve all 5 major risk factors of AF including obesity, hypertension, T2DM, OSA, and systemic inflammation.
The purpose of the study is to understand if MBS can affect the severity of AF and the toll AF's symptoms take on patients.
详细描述
This is randomized trial of 100 patients with BMI ≥35 kg/m2 and AF. Patients who met the initial screening criteria (including presence of at least 1% AF burden during a 2-week monitoring period with an ambulatory cardiac monitor) will be invited for possible enrollment. Patients will then be randomized 1:1 to MBS group versus nonsurgical control group and will be followed for 12 months (phase 1) and then for an additional 18 months (phase 2).
Interventions include Roux-en-Y Gastric Bypass or Sleeve Gastrectomy surgical procedures based on the shared medical decision between the bariatric surgeon and patients considering the patient's conditions. In the control group, patients are allowed to take anti-obesity medications (AOMs) that are not contraindicated in patients with AF at the discretion of obesity medicine specialists.
Lifestyle and risk factor modification in both groups will consist of targeted and personalized diet plans, exercise, and risk factor reduction, including optimal therapies for T2DM, hypertension, dyslipidemia, heart failure, coronary artery disease, and OSA.
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
盲法说明
Patients and investigators will not be blinded to treatment assignment. However, the clinical assessors of cardiac rhythm recorders are blinded to the study arms; Assessment of the primary endpoint will be based on the blinded downloads and interpretation of Zio XT Patch (iRhythm) data yielding the AF burden.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Entry into the study would require that the patient:
- •Is a candidate for general anesthesia
- •Is eligible for metabolic surgery (RYGB or SG)
- •Is ≥18 and ≤80 years old
- •has a BMI ≥35 and ≤65 kg/m2
- •has AF criteria, which:
- •Must be documented by EKG or cardiac monitor or Zio XT Patch
- •Must have symptomatic AF
- •In terms of types of AF, either paroxysmal AF with at least one episode lasting ≥5 minutes in the last 3 months prior to screening, or persistent AF, or longstanding AF.
- •Must have a minimum burden of 1% during a 2-week screening time with an ambulatory noninvasive cardiac monitor.
- •Must be assessed and confirmed by an expert cardiologist (e.g., cardiac electrophysiologist) to meet eligibility.
- •Patients without history of prior AF ablation/PVI procedure or with history of prior failed AF ablation/PVI procedure are eligible for the study.
- •Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin) for at least 3 months prior to entry, with HbA1c ≤12%.
- •Have the ability and willingness to participate in the study and agree to any of the arms involved in the study.
- •Able to understand the options and to comply with the requirements of each arm.
- •Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential.
- •Women, of childbearing age, must agree to use reliable method of contraception for 2 years.
排除标准
- •Significant cardiac valvular disease (planned to undergo cardiac valve intervention/surgery in the next 12 months)
- •Significant atherosclerotic disease (planned to undergo coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
- •Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
- •Classified as New York Heart Association Class IV
- •Left ventricular ejection fraction <20% at the time of screening
- •Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months
- •Prior bariatric and metabolic surgery of any kind (patients who had a gastric balloon or gastric band that were removed more than one year prior to enrollment are allowed to participate)
- •History of solid organ transplant
- •Type 1 diabetes or autoimmune diabetes
- •eGFR < 30 mL/min/1.73 m2 at screening or being on dialysis
- •Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
- •Anemia defined as hemoglobin less than 9 g/dL
- •Use of investigational therapy
- •Liver transaminase level >300 U/L
- •Significant alcohol use (average >2 drinks/day)
- •Presence of active malignancy (except non-melanoma skin cancer)
- •Life expectancy less than 3 years due to concomitant diseases
- •Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from metabolic surgery
- •Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
- •Unable to understand the risks, benefits and compliance requirements of study
- •Lack capacity to give informed consent
- •Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
- •Known adhesive allergies
研究组 & 干预措施
Metabolic Surgery
Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
干预措施: Roux-en-Y Gastric Bypass or Sleeve Gastrectomy (Procedure)
Control group (nonsurgical standard of care for obesity)
In the Control group, the subjects will be receiving standard of care for nonsurgical management of obesity, including possible AOMs that are not contraindicated in patients with AF at the discretion of obesity medicine specialists.
干预措施: Anti-Obesity Medication (AOM) treatment (Drug)
结局指标
主要结局
Relative change in total duration of being in atrial fibrillation (AF)
时间窗: First 52 weeks of the study
Relative change from baseline to 52 weeks in the percentage total duration of being in AF during a 2-week monitoring period (i.e., %burden), assessed by the Zio XT Patch (iRhythm).
次要结局
- Presence of at least 1 AF episode(First 52 weeks of the study)
- Change in number of AF episodes (≥30 seconds)(First 52 weeks of the study)
- Change in number of AF espisodes longer than 6 minutes(First 52 weeks of the study)
- Change in the longest AF duration(First 52 weeks of the study)
- Change in the second longest AF duration(First 52 weeks of the study)
- Change in the AF type(First 52 weeks of the study)
- Change in AF Symptom burden(First 52 weeks of the study)
- Relapse of AF after ablation(Throughout the study, 130 weeks)
- Change in cardiac structure(First 52 weeks of the study)
- Change in weight(First 52 weeks of the study)
研究者
Ali Aminian
Director of Bariatric & Metabolic Institute
The Cleveland Clinic