Impact of Bariatric Surgery on Heart Disease Compared to Standard Care (MIMS)

Danderyd Hospital

Status: Not yet enrolling

Conditions: Bariatric Surgery Candidate; Heart Diseases; Obesity, Morbid

Treatments: Procedure: Bariatric surgery; Procedure: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT06346145

MIMS study

2023-00453 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Bariatric surgery

Active Comparator group

Description:

Gastric bypass or gastric sleeve

Treatment:

Procedure: Bariatric surgery

Standard care

Active Comparator group

Description:

Standard obesity treatment offered in Swedish regions

Treatment:

Procedure: Standard care