200 Participants Needed

Bariatric Surgery for Cardiovascular Complications

(BRAVE Trial)

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Overseen BySumathy Rangarajan, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Population Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health, cardiac structure and function, genomics, proteomics and metabolomics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is bariatric surgery generally safe for humans?

Bariatric surgery, including procedures like gastric bypass and sleeve gastrectomy, is effective for weight loss and improving health conditions related to obesity, but it can have complications such as nutritional deficiencies, surgical risks, and gastrointestinal issues.12345

How does bariatric surgery differ from other treatments for cardiovascular complications?

Bariatric surgery is unique because it not only helps achieve significant and lasting weight loss but also addresses obesity-related illnesses, including cardiovascular complications, by altering the digestive system to limit food intake and nutrient absorption. Unlike non-surgical weight management, it involves surgical procedures like gastric bypass and sleeve gastrectomy, which can lead to both early and late complications but offer a more permanent solution for morbid obesity.25678

What data supports the effectiveness of this treatment for cardiovascular complications?

Research shows that bariatric surgery, including procedures like Roux-en-Y gastric bypass and biliopancreatic diversion, leads to significant long-term weight loss and improvements in metabolic and cardiovascular health, especially in severely obese patients.910111213

Who Is on the Research Team?

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Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC

Principal Investigator

Population Health Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with severe obesity (BMI ≥35 kg/m2) and high-risk cardiovascular disease, including heart failure, stroke history, or peripheral arterial disease. Candidates must not have had recent hospital admissions for heart issues or bariatric surgery (except gastric banding), be pregnant, or unable to consent.

Inclusion Criteria

I have had surgery or amputation due to poor blood flow in my limbs or have significant narrowing of my arteries.
Body mass index ≥35 kg/m2
I have had a stroke before.
See 5 more

Exclusion Criteria

I cannot have weight loss surgery due to health risks.
Life expectancy <2 years from non-cardiovascular causes
Inability to provide informed consent
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either bariatric surgery or medical weight management to reduce cardiovascular events

6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bariatric Surgery
  • Medical Weight Management
Trial Overview The study compares the effectiveness of bariatric surgery versus medical weight management in reducing major cardiovascular events in severely obese patients with high-risk CVD. It also assesses the cost-effectiveness and impact on mental health and cardiac function.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Bariatric SurgeryExperimental Treatment1 Intervention
Group II: Medical Weight ManagementActive Control1 Intervention

Bariatric Surgery is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Bariatric Surgery for:
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Approved in United States as Bariatric Surgery for:
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Approved in Canada as Bariatric Surgery for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials
165
Recruited
717,000+

Published Research Related to This Trial

Bariatric surgery, such as Roux-en-Y gastric bypass and biliopancreatic diversion, is effective for long-term weight loss and reducing health risks in morbidly obese individuals, but it can lead to serious nutritional complications that may require revisional surgery.
In a study of four patients who underwent revisional surgery due to complications, one patient died, highlighting that while revision surgery is rare, it carries increased risks and can involve different surgical approaches depending on the patient's condition.
Revisional surgery in severe nutritional complications after bariatric surgical procedures: report of four cases from a single institution and review of the literature.Braga, JGR., Concon, MM., Lima, AP., et al.[2021]
Surgical methods, particularly vertical banded gastroplasty and Roux-Y gastric bypass, are currently the most effective treatments for severe obesity, as nonsurgical methods often fail to achieve significant long-term weight loss.
The success of these surgeries relies more on patient motivation and behavior than on the technical aspects of the procedures, suggesting that psychological support and lifestyle changes are crucial for achieving and maintaining weight loss.
Overview of surgical techniques for treating obesity.Kral, JG.[2018]
Bariatric surgery, specifically Roux en-Y Gastric Bypass (RYGB), leads to significant long-term weight loss and improves insulin sensitivity and metabolic health in obese individuals, as shown by various assessments including body composition and insulin sensitivity tests.
The study found that changes in fat cell size and morphology after RYGB are linked to improved metabolic profiles, suggesting that targeting fat cell size reduction could be a future strategy for enhancing insulin sensitivity in obesity treatment.
The 2020 ESPEN Arvid Wretlind lecture: Metabolic response in bariatric surgery - Mechanisms and clinical implications.Thorell, A.[2021]

Citations

Revisional surgery in severe nutritional complications after bariatric surgical procedures: report of four cases from a single institution and review of the literature. [2021]
Overview of surgical techniques for treating obesity. [2018]
The 2020 ESPEN Arvid Wretlind lecture: Metabolic response in bariatric surgery - Mechanisms and clinical implications. [2021]
Ten-year outcomes of Roux-en-Y gastric bypass are equivalent in patients with Medicare disability and non-Medicare patients. [2019]
Metabolic and cardiovascular improvements after biliopancreatic diversion in a severely obese patient. [2018]
[Obesity surgery and its adverse effects]. [2016]
Objective comparison of complications resulting from laparoscopic bariatric procedures. [2006]
[Nutritional status after surgical treatment of obesity]. [2008]
Duodenal stump leak following a duodenal switch: A case report. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Gastrointestinal Complications After Bariatric Surgery. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Preoperative cardiac screening using NT-proBNP in obese patients 50 years and older undergoing bariatric surgery: a study of 310 consecutive patients. [2022]
Aortic complications after bariatric surgery. [2022]
[Bariatric surgery: surgical techniques and their complications]. [2016]
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