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Can bariatric surgery save hearts? major trial aims to find out

NCT ID NCT05531474

Disease control Sponsor: Population Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether bariatric surgery (like gastric bypass) can safely reduce the risk of major heart problems—such as heart attacks, strokes, and heart failure—in people with severe obesity and high heart risk. About 700 participants will be randomly assigned to either surgery or standard medical weight management. The trial also looks at effects on mental health, thinking skills, and cost-effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bariatric surgery (gastric bypass, sleeve gastrectomy, or duodenal switch)
What this could lead to
If it works, this could show that bariatric surgery is a safe and effective way to lower the chance of major heart problems in people with severe obesity and existing heart disease.
What could go wrong
This is a large, ongoing trial, but surgery carries risks like infection or complications. Results may not apply to everyone, and the benefit over medical weight management is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are \>55 years of age 2. Age ≥18 years 3. High-risk CVD, defined as the presence of any one of the following: 1. High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries) 2. Left ventricular ejection fraction (LVEF) \< 40% 3. Heart failure with preserved ejection fraction (LVEF \> 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \> 300 pg/ml or BNP \> 100 pg/ml in the past 12 months 4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score 5. History of any stroke 6. Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis) Exclusion Criteria: 1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization 2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization. 3. Pregnancy 4. Contraindication to bariatric surgery 5. Prior bariatric surgery, other than gastric banding 6. Life expectancy \<2 years from non-cardiovascular causes 7. Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder morbid obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric surgery candidate Cardiovascular complication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.