Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial

  • STATUS
    Recruiting
  • End date
    May 4, 2023
  • participants needed
    60
  • sponsor
    Hamilton Health Sciences Corporation
Updated on 4 February 2021
arteriopathy
diabetes
peripheral artery disease
stenosis
body mass index
hypertension
stroke
heart failure
percutaneous coronary intervention
coronary disease
bypass surgery
transient ischemic attack
bariatric surgery

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).

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.

Details
Condition Morbid obesity, Cardiovascular Disease, Cardiovascular Disease, severe obesity, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment Bariatric Surgery
Clinical Study IdentifierNCT04226664
SponsorHamilton Health Sciences Corporation
Last Modified on4 February 2021

Eligibility

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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