Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Randomized Controlled Trial (BRAVE)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Crossover rate
研究概览
简要总结
Pilot multicentre, open-label, parallel-arm randomized controlled trial (RCT) of 60 patients to demonstrate the feasibility of enrolling patients with high-risk cardiovascular disease (CVD) into an RCT of bariatric surgery versus medical weight management (MWM).
详细描述
STUDY OBJECTIVE The primary objective of this pilot study is to assess the feasibility of an RCT of bariatric surgery compared to MWM in patients with morbid obesity and high-risk CVD. If we can demonstrate that this trial is feasible, the next step would be to conduct a large-scale RCT to evaluate the efficacy of bariatric surgery for the reduction of cardiovascular complications in this patient population.
STUDY AIMS:
- To demonstrate that enrolment of high-risk CVD patients into a bariatric surgery RCT is feasible.
- To show that it is feasible to perform bariatric surgery in >80% of patients in the intervention arm within 30 days of randomization.
- To obtain preliminary information on the perioperative risks of bariatric surgery in patients with high-risk CVD.
STUDY HYPOTHESES Study enrollment will be feasible at a rate of at least 1.25 patients per centre per month. Timely delivery of the intervention is possible, with >80% of patients undergoing bariatric surgery within 30 days of randomization. The rate of crossover between the control and intervention arms will be low at <2.5% per year. 30-day mortality rates in the intervention group will be comparable to that of an age and gender matched cohort without CVD who had bariatric surgery at the 2 study sites during the study period.
DESIGN The present study is a multicentre, open-label, parallel-arm feasibility RCT with blinded endpoint assessment (PROBE design) of bariatric surgery compared to MWM in patients with morbid obesity and high-risk CVD.
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 >35 kg/m2
- •Age ≥18 years
- •High-risk CVD, defined as the presence of any one of the following:
- •History of MI, multi-vessel percutaneous coronary intervention or multi-vessel coronary artery bypass grafting; OR
- •Coronary artery disease (CAD) with documented stenoses ≥50% in 2 or more major coronary arteries; OR
- •Symptomatic HF (New York Heart Association class ≥2) on optimal HF therapy for ≥3 months, AND documented HF hospitalization within the last 12 months, OR baseline N-terminal pro B-type natriuretic peptide (NT-pro BNP) >400 pg/ml;44, 45 OR
- •Documented AF with CHA2DS2-VASc stroke risk score (congestive heart failure/ left ventricular dysfunction, hypertension, age ≥ 75 years [2 points], diabetes, history of stroke/ transient ischemic attack [2 points], vascular disease, age 65-74 years and female sex) of ≥2; OR
- •History of ischemic stroke; OR
- •Peripheral artery disease, defined as prior aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, infra-inguinal arteries or carotids; or limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis
- •Patient is deemed eligible to undergo bariatric surgery according to local practice guidelines
排除标准
- •Hospital admission for HF within 30 days of enrolment
- •Myocardial infarction, stroke or coronary revascularization in prior 30 days.
- •Percutaneous coronary intervention with a drug eluting stent in prior 90 days.
- •Contraindication to bariatric surgery (atrophic gastritis, diabetes mellitus type 1, prior laparotomy, liver cirrhosis with portal hypertension, uncontrolled drug or alcohol dependence, prior bariatric surgery, massive ventral hernia, severe chronic obstructive pulmonary disease)
- •Life expectancy <2 years from non-cardiovascular causes.
- •Risk of general anesthesia deemed too excessive
- •Current drug or alcohol dependency (within 6 months of referral)
- •Recent major cancer (life threatening, within last 2 years)
- •Untreated or inadequately treated psychiatric illness
- •Inability to provide informed consent
结局指标
主要结局
Crossover rate
时间窗: At study completion (an average of 1.5 years follow-up)
Crossover rate between control and intervention arm
Recruitment rate
时间窗: 24 months (or when recruitment is complete)
Recruitment rate (target of 60 patients over 24 months or 1.25 patients per centre per month)
Time to intervention administration
时间窗: 30 days
Target of bariatric surgery performed within 30 days of randomization in \>80%
次要结局
- Composite outcome of cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)(12 months, and through study completion (an average of 1.5 years follow-up))
- Change in New York Heart Association (NYHA) Functional Classification at 1 year(12 months)
- Change in BMI at 1 year(12 months)
- Number of participants with new onset Atrial Fibrillation (AF) at 1 year(12 months, and through study completion (an average of 1.5 years follow-up))
- Change in weight at 1 year(12 months)
- Change in 6-minute walk test distance (m) at 1 year(12 months)
- Change in percent excess weight loss (%) at 1 year(12 months)
- Change in 36-Item Short Form Survey (SF-36) questionnaire score at 1 year(12 months)
- Change in EuroQuol (EQ-5D-5L) quality of life questionnaire score at 1 year(12 months)