Clinical trial

Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

Opening soon · Not applicable · 0 countries · Registry ID NCT06346145

Opening soonNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid, Bariatric Surgery Candidate, Heart Diseases

Full registry criteria

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.

Treatments and study arms

Bariatric surgery

Procedure

Type of surgery assigned by surgeon in consultation with patient

Standard care

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.

Primary outcomes

MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis.Through study completion, expected average of 6 years

Data will be obtained for the Swedish national patient registry and other national quality registries.

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.