Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDanderyd Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

MI (as defined by the universal definition of MI) at least 1 year before inclusion.

BMI ≥35 kg/m2

Written informed consent obtained

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bariatric surgery

    Procedure/Surgery

    Type of surgery assigned by surgeon in consultation with patient

  • Standard care

    Procedure/Surgery

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Bariatric surgeryActive comparator 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

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.

Data will be obtained for the Swedish national patient registry and other national quality registries.

Time frame
Through study completion, expected average of 6 years

Secondary outcomes

1

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.

Time frame
Through study completion, expected average of 6 years
2

All-cause mortality

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

Time frame
Through study completion, expected average of 6 years
3

Cardiovascular death

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

Time frame
Through study completion, expected average of 6 years
4

Remission of type 2 diabetes (T2D) and hypertension

Number of patients in remission

Time frame
Through study completion, expected average of 6 years

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.

Data will be obtained for the Swedish national patient registry and other national quality registries.

Time frame
Through study completion, expected average of 6 years
2

Body weight change

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

Time frame
5-year follow-up
3

Change in quality of life

Assessed by EQ-5D-5L questionnaire

Time frame
5-year follow-up
4

All-cause hospitalizations

Based on ICD 10 diagnosis in national patient registry and other national quality registries

Time frame
Through study completion, expected average of 6 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danderyd Hospital

Lead sponsor

Karolinska Institutet

Collaborator

The 21 healthcare regions in Sweden

Collaborator

This trial is not recruiting at the moment. You can still explore other options: