Clinical trial NCT06346145: Impact of Bariatric Surgery on Heart Disease Compared to Standard Care
Official title: A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Heart Diseases
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: The 21 healthcare regions in Sweden
First posted: 2024-04-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Through study completion, expected average of 6 years
Secondary outcomes:
measure: Total event rate
timeFrame: Through study completion, expected average of 6 years
measure: All-cause mortality
timeFrame: Through study completion, expected average of 6 years
measure: Cardiovascular death
timeFrame: Through study completion, expected average of 6 years
measure: Remission of type 2 diabetes (T2D) and hypertension
timeFrame: Through study completion, expected average of 6 years
measure: Myocardial infarction
timeFrame: Through study completion, expected average of 6 years
measure: Stroke
timeFrame: Through study completion, expected average of 6 years
measure: Myocardial revascularization (not related to MI)
timeFrame: Through study completion, expected average of 6 years
measure: hospital admission because of heart failure as a primary ICD diagnosis.
timeFrame: Through study completion, expected average of 6 years
measure: hospital admission because of atrial fibrillation as a primary ICD diagnosis.
timeFrame: Through study completion, expected average of 6 years
Other outcomes:
measure: Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity.
timeFrame: Through study completion, expected average of 6 years
measure: Body weight change
timeFrame: 5-year follow-up
measure: Change in quality of life
timeFrame: 5-year follow-up
measure: All-cause hospitalizations
timeFrame: Through study completion, expected average of 6 years
measure: Change in quality of life
timeFrame: 5-year follow-up
Locations:
Study officials:
affiliation: Karolinska Institutet/Danderyd hospital
name: Erik Näslund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naslund E, Stenberg E, Hofmann R, Ottosson J, Sundbom M, Marsk R, Svensson P, Szummer K, Jernberg T. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Previous Myocardial Infarction and Severe Obesity: A Nationwide Cohort Study. Circulation. 2021 Apr 13;143(15):1458-1467. doi: 10.1161/CIRCULATIONAHA.120.048585. Epub 2020 Oct 26.