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Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial (BRAVE)

Primary Purpose

Obesity, Morbid, Cardiovascular Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Bariatric surgery

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Bariatric Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Body mass index >35 kg/m2
Age ≥18 years
High-risk CVD, defined as the presence of any one of the following:
1. History of MI, multi-vessel percutaneous coronary intervention or multi-vessel coronary artery bypass grafting; OR
2. Coronary artery disease (CAD) with documented stenoses ≥50% in 2 or more major coronary arteries; OR
3. 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
4. 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
5. History of ischemic stroke; OR
6. 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

Exclusion Criteria:

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.
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

Sites / Locations

St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment rate

Recruitment rate (target of 60 patients over 24 months or 1.25 patients per centre per month)

Time to intervention administration

Target of bariatric surgery performed within 30 days of randomization in >80%

Crossover rate

Crossover rate between control and intervention arm

Secondary Outcome Measures

Change in weight at 1 year

Change in weight in kilograms at 1 year

Change in BMI at 1 year

BMI (kg/m^2) will be calculated using weight in kg at 1 year, and height

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

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.

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.

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.

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.

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".

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.

Full Information

NCT ID

NCT04226664

First Posted

January 3, 2020

Last Updated

March 14, 2022

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Population Health Research Institute, St. Joseph's Healthcare Hamilton

1. Study Identification

Unique Protocol Identification Number

NCT04226664

Brief Title

Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial

Acronym

BRAVE

Official Title

Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Randomized Controlled Trial (BRAVE)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2020 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

Population Health Research Institute, St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Morbid, Cardiovascular Diseases

Keywords

Bariatric Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Bariatric surgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment rate

Description

Recruitment rate (target of 60 patients over 24 months or 1.25 patients per centre per month)

Time Frame

24 months (or when recruitment is complete)

Title

Time to intervention administration

Description

Target of bariatric surgery performed within 30 days of randomization in >80%

Time Frame

30 days

Title

Crossover rate

Description

Crossover rate between control and intervention arm

Time Frame

At study completion (an average of 1.5 years follow-up)

Secondary Outcome Measure Information:

Title

Change in weight at 1 year

Description

Change in weight in kilograms at 1 year

Time Frame

12 months

Title

Change in BMI at 1 year

Description

BMI (kg/m^2) will be calculated using weight in kg at 1 year, and height

Time Frame

12 months

Title

Composite outcome of cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)

Description

Composite outcome of cardiovascular mortality, myocardial infarction, stroke and hospitalization for heart failure

Time Frame

12 months, and through study completion (an average of 1.5 years follow-up)

Title

Change in percent excess weight loss (%) at 1 year

Description

Time Frame

12 months

Title

Change in New York Heart Association (NYHA) Functional Classification at 1 year

Description

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.

Time Frame

12 months

Title

Change in 6-minute walk test distance (m) at 1 year

Description

Time Frame

12 months

Title

Change in 36-Item Short Form Survey (SF-36) questionnaire score at 1 year

Description

Time Frame

12 months

Title

Change in EuroQuol (EQ-5D-5L) quality of life questionnaire score at 1 year

Description

Time Frame

12 months

Title

Number of participants with new onset Atrial Fibrillation (AF) at 1 year

Description

Will determine the number of participants who receive a new clinical diagnosis of AF during the study follow-up.

Time Frame

12 months, and through study completion (an average of 1.5 years follow-up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tara McCready, PhD, MBA

Phone

905-521-2100

tara.mccready@phri.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Wanna Fong

Phone

905-521-2100

wanna.fong@phri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Wong, MD MPH FRCPC

Organizational Affiliation

PHRI, Hamilton Health Sciences, McMaster University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Aristithes Doumouras, MD MPH FRCSC

Organizational Affiliation

St. Joseph's Healthcare, McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aristithes Doumouras, MD MPH FRCSC

First Name & Middle Initial & Last Name & Degree

Jorge Wong, MD MPH FRCPC

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.phri.ca/

Description

Population Health Research Institute

URL

https://www.stjoes.ca/hospital-services/surgical-services/bariatric-surgery

Description

St. Joseph's Heathcare Hamilton Bariatric Surgery Program

Learn more about this trial

Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial

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