Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2030-05-01

Brief Summary

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Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.

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Detailed Description

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Conditions

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Obesity, Morbid Bariatric Surgery Candidate Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bariatric surgery

Gastric bypass or gastric sleeve

Group Type ACTIVE_COMPARATOR

Bariatric surgery

Intervention Type PROCEDURE

Type of surgery assigned by surgeon in consultation with patient

Standard care

Standard obesity treatment offered in Swedish regions

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type PROCEDURE

Standard care can consist of dietary intervention, physiotherapy or drug treatment in accordance to the care given in the region of Sweden where the patient resides.

Interventions

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Bariatric surgery

Type of surgery assigned by surgeon in consultation with patient

Intervention Type PROCEDURE

Standard care

Standard care can consist of dietary intervention, physiotherapy or drug treatment in accordance to the care given in the region of Sweden where the patient resides.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* MI (as defined by the universal definition of MI) at least 1 year before inclusion.
* BMI ≥35 kg/m2
* Written informed consent obtained

Exclusion Criteria

* Any condition that may influence the patient's ability to comply with study protocol.
* Earlier MBS or operation for gastric or duodenal ulcer or reflux disease
* Other condition that makes patient not suitable for MBS according to responsible surgeon and anesthesiologist
* Unable to understand Swedish.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No