Study Summary
This trial is testing whether bariatric surgery (weight loss surgery) is better than medical weight management (diet and lifestyle changes) for people with high-risk cardiovascular disease.
Eligible Conditions
- Cardiovascular Disease
- Morbid Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 9 Secondary · Reporting Duration: At study completion (an average of 1.5 years follow-up)
12 months
Change in 36-Item Short Form Survey (SF-36) questionnaire score at 1 year
Change in 6-minute walk test distance (m) at 1 year
Change in BMI at 1 year
Change in EuroQuol (EQ-5D-5L) quality of life questionnaire score at 1 year
Change in New York Heart Association (NYHA) Functional Classification at 1 year
Change in percent excess weight loss (%) at 1 year
Change in weight at 1 year
Year 5
Composite outcome of cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)
Number of participants with new onset Atrial Fibrillation (AF) at 1 year
Month 24
Recruitment rate
30 days
Time to intervention administration
Year 5
Crossover rate
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
60 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention · No Placebo Group · N/A
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Intervention
Procedure
ActiveComparator Group · 1 Intervention: Bariatric surgery · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at study completion (an average of 1.5 years follow-up)
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
344 Previous Clinical Trials
272,171 Total Patients Enrolled
Population Health Research InstituteOTHER
143 Previous Clinical Trials
669,167 Total Patients Enrolled
St. Joseph's Healthcare HamiltonOTHER
180 Previous Clinical Trials
25,155 Total Patients Enrolled
Aristithes Doumouras, MD MPH FRCSCPrincipal InvestigatorSt. Joseph's Healthcare, McMaster University
Jorge Wong, MD MPH FRCPCPrincipal InvestigatorPHRI, Hamilton Health Sciences, McMaster University
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patient is deemed eligible to undergo bariatric surgery according to local practice guidelines.
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Conditions
Cancer Related
Treatments