A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
| Registry | NCT06346145, acronym MIMS |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: none, treatment |
|---|
| Enrollment | 500 (Estimated) |
|---|
| Sponsor | Danderyd Hospital (Other); collaborators: Karolinska Institutet, The 21 healthcare regions in Sweden |
|---|
| Conditions | Obesity, Morbid, Bariatric Surgery Candidate, Heart Diseases |
|---|
| Interventions | Bariatric surgery, Standard care (Procedure) |
|---|
| Dates | start 2024-05-01 (estimated), primary completion 2028-05-01 (estimated), completion 2030-05-01 (estimated), first posted 2024-04-03, last updated 2024-04-03 |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Obesity, Morbid All trials for Bariatric Surgery Candidate All trials of Bariatric surgery All trials of Standard care
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Bariatric surgery | Active comparator | Procedure: Bariatric surgery | Gastric bypass or gastric sleeve |
| Standard care | Active comparator | Procedure: Standard care | Standard obesity treatment offered in Swedish regions |
- 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.
+Outcome measures
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.
Secondary outcomes
- Total event rate [Through study completion, expected average of 6 years]: Based on events listed in the primary outcome measure. Data will be obtained for the Swedish national patient registry and other national quality registries.
- All-cause mortality [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
- Cardiovascular death [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
- Remission of type 2 diabetes (T2D) and hypertension [Through study completion, expected average of 6 years]: Number of patients in remission
- Myocardial infarction [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
- Stroke [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
- Myocardial revascularization (not related to MI) [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
- hospital admission because of heart failure as a primary ICD diagnosis. [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
- hospital admission because of atrial fibrillation as a primary ICD diagnosis. [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national national quality registries.
Other outcomes
- 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. [Through study completion, expected average of 6 years]: Data will be obtained for the Swedish national patient registry and other national quality registries.
- Body weight change [5-year follow-up]: Change in kg from baseline during long-term follow-up.
- Change in quality of life [5-year follow-up]: Assessed by EQ-5D-5L questionnaire
- All-cause hospitalizations [Through study completion, expected average of 6 years]: Based on ICD 10 diagnosis in national patient registry and other national quality registries
- Change in quality of life [5-year follow-up]: Assessed by RAND 36
+Eligibility
Sex: All, ages: 18 Years to 70 Years
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.
+Publications
- 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. PMID 33103469
+Investigators
- Erik Näslund, MD, PhD, Principal investigator, Karolinska Institutet/Danderyd hospital
+Funding