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

March 28, 2024 updated by: Erik Näslund, Danderyd Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bariatric surgery
Gastric bypass or gastric sleeve
Procedure: Bariatric surgery
Type of surgery assigned by surgeon in consultation with patient
Active Comparator: Standard care
Standard obesity treatment offered in Swedish regions
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national patient registry and other national quality registries.
Through study completion, expected average of 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total event rate
Time Frame: 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.
Through study completion, expected average of 6 years
All-cause mortality
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years
Cardiovascular death
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years
Remission of type 2 diabetes (T2D) and hypertension
Time Frame: Through study completion, expected average of 6 years
Number of patients in remission
Through study completion, expected average of 6 years
Myocardial infarction
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years
Stroke
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years
Myocardial revascularization (not related to MI)
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years
hospital admission because of heart failure as a primary ICD diagnosis.
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years
hospital admission because of atrial fibrillation as a primary ICD diagnosis.
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Through study completion, expected average of 6 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national patient registry and other national quality registries.
Through study completion, expected average of 6 years
Body weight change
Time Frame: 5-year follow-up
Change in kg from baseline during long-term follow-up.
5-year follow-up
Change in quality of life
Time Frame: 5-year follow-up
Assessed by EQ-5D-5L questionnaire
5-year follow-up
All-cause hospitalizations
Time Frame: Through study completion, expected average of 6 years
Based on ICD 10 diagnosis in national patient registry and other national quality registries
Through study completion, expected average of 6 years
Change in quality of life
Time Frame: 5-year follow-up
Assessed by RAND 36
5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Collaborators

Karolinska Institutet
The 21 healthcare regions in Sweden

Investigators

  • Principal Investigator: Erik Näslund, MD, PhD, Karolinska Institutet/Danderyd hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIMS study
  • 2023-00453 (Other Grant/Funding Number: Swdeish research council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared openly at a repository since it contains personal data. Data will be made available upon request after ensuring compliance with relevant legislation and Karolinska Institutet guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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