Obesity, MorbidBRAVENCT04226664
Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial
A study testing Bariatric surgery in people with Obesity, Morbid and Cardiovascular Diseases, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Cardiovascular Diseases
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2020to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
- Pregnancy
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Aristithes Doumouras, MD MPH FRCSC
Jorge Wong, MD MPH FRCPC
About this study
Official title: Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Randomized Controlled Trial (BRAVE)
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).
Read the detailed 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:
- 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.
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.
- Conditions
- Obesity, Morbid, Cardiovascular Diseases
- Being tested
- Bariatric surgery
- Keywords
- Bariatric Surgery
- Medical subject headings
- Obesity, Morbid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Although there may be slight variation by centre, Gastric Bypass generally involves creation of a 30-50 cc stomach pouch, which is anastamosed with a Roux limb of jejunum 75-100 cm in length and a biliary limb of 20-30 cm in length. The operation creates a small gastric pouch, with nutrients bypassing the duodenum and proximal jejunum. Sleeve Gastrectomy involves decreasing the size of the stomach to approximately 15% of its original size by resecting a large portion of the stomach along the greater curvature.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Procedure: Bariatric surgery |
| Control | No intervention | Medical Weight Management (MWM) corresponds to the standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate (target of 60 patients over 24 months or 1.25 patients per centre per month)
Measured: 24 months (or when recruitment is complete)
Time to intervention administration
Target of bariatric surgery performed within 30 days of randomization in >80%
Measured: 30 days
Crossover rate
Crossover rate between control and intervention arm
Measured: At study completion (an average of 1.5 years follow-up)
Secondary outcomes (9)
Change in weight at 1 year
Change in weight in kilograms at 1 year
Measured: 12 months
Change in BMI at 1 year
BMI (kg/m^2) will be calculated using weight in kg at 1 year, and height
Measured: 12 months
Composite outcome of cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)
Composite outcome of cardiovascular mortality, myocardial infarction, stroke and hospitalization for heart failure
Measured: 12 months, and through study completion (an average of 1.5 years follow-up)
Change in percent excess weight loss (%) at 1 year
Excess weight loss is a standard outcome measure in obesity research. It is calculated as the percentage of excess body weight lost after surgery. Excess body weight (kg) is calculated as current weight (kg) minus ideal body weight (kg) for a given height. Ideal body weight (kg) is taken from standardized tables.
Measured: 12 months
Change in New York Heart Association (NYHA) Functional Classification at 1 year
NYHA Class is a standardized classification system for severity of heart failure symptoms, and ranges from class I to class IV, with IV being the most severe symptoms and class.
Measured: 12 months
Change in 6-minute walk test distance (m) at 1 year
The 6 Minute Walk Test is an exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome. Longer distances indicate better performance.
Measured: 12 months
Change in 36-Item Short Form Survey (SF-36) questionnaire score at 1 year
The SF-36 is a measure of health-related quality-of-life. It includes eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: 12 months
Change in EuroQuol (EQ-5D-5L) quality of life questionnaire score at 1 year
EQ-5D-5L is a standardized instrument for measuring health status, which includes a descriptive system asking about 5 health dimensions as well as an evaluation of overall health status with a visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels from which respondents choose one response: no problems, slight problems, moderate problems, severe problems and extreme problems. The visual analogue scale asks individuals to mark their health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine".
Measured: 12 months
Number of participants with new onset Atrial Fibrillation (AF) at 1 year
Will determine the number of participants who receive a new clinical diagnosis of AF during the study follow-up.
Measured: 12 months, and through study completion (an average of 1.5 years follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start30 Oct 2020
- Primary completionFeb 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals who meet study eligibility criteria will be randomized in 1:1 fashion to bariatric surgery (intervention arm) or MWM (control arm).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Jorge Wong, MD MPH FRCPC, Principal investigator, PHRI, Hamilton Health Sciences, McMaster UniversityAristithes Doumouras, MD MPH FRCSC, Principal investigator, St. Joseph's Healthcare, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226664
- Sponsor's protocol ID
- 8047
- Acronym
- BRAVE
- Status last verified
- Mar 2022
- First submitted
- 3 Jan 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Randomized Controlled Trial (BRAVE)
- ClinicalTrials.gov ID
- NCT04226664
- Acronym / sponsor ID
- BRAVE / 8047
- Conditions
- Obesity, Morbid, Cardiovascular Diseases
- Keywords
- Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute, St. Joseph's Healthcare Hamilton
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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:
- 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals who meet study eligibility criteria will be randomized in 1:1 fashion to bariatric surgery (intervention arm) or MWM (control arm).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: Bariatric surgeryBariatric 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. |
| Control | No intervention | –Medical Weight Management (MWM) corresponds to the standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Body mass index >35 kg/m2
- Age ≥18 years
- High-risk CVD, defined as the presence of any one of the following:
- Patient is deemed eligible to undergo bariatric surgery according to local practice guidelines
Key exclusion criteria (11 listed)
- 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.
- Pregnancy
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryAlthough there may be slight variation by centre, Gastric Bypass generally involves creation of a 30-50 cc stomach pouch, which is anastamosed with a Roux limb of jejunum 75-100 cm in length and a biliary limb of 20-30 cm in length. The operation creates a small gastric pouch, with nutrients bypassing the duodenum and proximal jejunum. Sleeve Gastrectomy involves decreasing the size of the stomach to approximately 15% of its original size by resecting a large portion of the stomach along the greater curvature. | Procedure or surgery | Intervention |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 30 days
Target of bariatric surgery performed within 30 days of randomization in >80%
Crossover rate
Time frame: At study completion (an average of 1.5 years follow-up)
Crossover rate between control and intervention arm
9 secondary outcomes
Change in weight at 1 year
Time frame: 12 months
Change in BMI at 1 year
Time frame: 12 months
Composite outcome of cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)
Time frame: 12 months, and through study completion (an average of 1.5 years follow-up)
Change in percent excess weight loss (%) at 1 year
Time frame: 12 months
Change in New York Heart Association (NYHA) Functional Classification at 1 year
Time frame: 12 months
Change in 6-minute walk test distance (m) at 1 year
Time frame: 12 months
Change in 36-Item Short Form Survey (SF-36) questionnaire score at 1 year
Time frame: 12 months
Change in EuroQuol (EQ-5D-5L) quality of life questionnaire score at 1 year
Time frame: 12 months
Number of participants with new onset Atrial Fibrillation (AF) at 1 year
Time frame: 12 months, and through study completion (an average of 1.5 years follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Population Health Research InstituteLink provided by the sponsor.
- St. Joseph's Heathcare Hamilton Bariatric Surgery ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity, Morbid
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Wong, MD MPH FRCPC principal investigator
PHRI, Hamilton Health Sciences, McMaster University
Aristithes Doumouras, MD MPH FRCSC principal investigator
St. Joseph's Healthcare, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Obesity, Morbid and Cardiovascular Diseases, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tara McCready, PhD, MBA (905-521-2100, tara.mccready@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 24 months (or when recruitment is complete)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.