Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

Heart Diseases Clinical Trial

— MIMS  

Official title:

A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346145
• Other study ID #: MIMS study
• Secondary ID: 2023-00453
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2030

Study information

• Verified date: March 2024
• Source: Danderyd Hospital
• Contact: Erik Näslund, MD, PhD
• Phone: 46812355017
• Email: Erik.Naslund[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Heart Diseases
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Type of surgery assigned by surgeon in consultation with patient
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Danderyd Hospital	Karolinska Institutet, The 21 healthcare regions in Sweden

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Data will be obtained for the Swedish national patient registry and other national quality registries.	Through study completion, expected average of 6 years
Other	Body weight change	Change in kg from baseline during long-term follow-up.	5-year follow-up
Other	Change in quality of life	Assessed by EQ-5D-5L questionnaire	5-year follow-up
Other	All-cause hospitalizations	Based on ICD 10 diagnosis in national patient registry and other national quality registries	Through study completion, expected average of 6 years
Other	Change in quality of life	Assessed by RAND 36	5-year follow-up
Primary	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.	Data will be obtained for the Swedish national patient registry and other national quality registries.	Through study completion, expected average of 6 years
Secondary	Total event rate	Based on events listed in the primary outcome measure. Data will be obtained for the Swedish national patient registry and other national quality registries.	Through study completion, expected average of 6 years
Secondary	All-cause mortality	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years
Secondary	Cardiovascular death	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years
Secondary	Remission of type 2 diabetes (T2D) and hypertension	Number of patients in remission	Through study completion, expected average of 6 years
Secondary	Myocardial infarction	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years
Secondary	Stroke	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years
Secondary	Myocardial revascularization (not related to MI)	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years
Secondary	hospital admission because of heart failure as a primary ICD diagnosis.	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years
Secondary	hospital admission because of atrial fibrillation as a primary ICD diagnosis.	Data will be obtained for the Swedish national national quality registries.	Through study completion, expected average of 6 years