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NCT Number: NCT06346145

Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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.

Secondary outcomes

  1. 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.

  2. All-cause mortality

    Time frame: Through study completion, expected average of 6 years

    Data will be obtained for the Swedish national national quality registries.

  3. Cardiovascular death

    Time frame: Through study completion, expected average of 6 years

    Data will be obtained for the Swedish national national quality registries.

  4. Remission of type 2 diabetes (T2D) and hypertension

    Time frame: Through study completion, expected average of 6 years

    Number of patients in remission

  5. Myocardial infarction

    Time frame: Through study completion, expected average of 6 years

    Data will be obtained for the Swedish national national quality registries.

  6. Stroke

    Time frame: Through study completion, expected average of 6 years

    Data will be obtained for the Swedish national national quality registries.

  7. 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.

  8. 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.

  9. 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.

Other outcomes

  1. 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.

  2. Body weight change

    Time frame: 5-year follow-up

    Change in kg from baseline during long-term follow-up.

  3. Change in quality of life

    Time frame: 5-year follow-up

    Assessed by EQ-5D-5L questionnaire

  4. 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

  5. Change in quality of life

    Time frame: 5-year follow-up

    Assessed by RAND 36

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Näslund, MD, PhD

CONTACT

[email protected]

46812355017

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Collaborators

  • Karolinska Institutet
  • The 21 healthcare regions in Sweden

Registry information

Official study title

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

Acronym: MIMS

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Apr 3, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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