Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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: 1. To demonstrate that enrolment of high-risk CVD patients into a bariatric surgery RCT is feasible. 2. To show that it is feasible to perform bariatric surgery in >80% of patients in the intervention arm within 30 days of randomization. 3. 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. Individuals who meet study eligibility criteria will be randomized in 1:1 fashion to bariatric surgery (intervention arm) or MWM (control arm). Bariatric surgery will consist of laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy, performed at the discretion of the surgeon and according to local standards. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04226664
Study type	Interventional
Source	Hamilton Health Sciences Corporation
Contact	Tara McCready, PhD, MBA
Phone	905-521-2100
Email	tara.mccready@phri.ca
Status	Recruiting
Phase	N/A
Start date	October 30, 2020
Completion date	May 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial — BRAVE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms