Impact of Bariatric Surgery on Heart Disease Compared to Standard Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric surgery, Standard care.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid, Bariatric Surgery Candidate, Heart Diseases. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
Overview
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.
Interventions
- Procedure Bariatric surgery
Type of surgery assigned by surgeon in consultation with patient - 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.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- Total event rate [Time frame: Through study completion, expected average of 6 years]
- All-cause mortality [Time frame: Through study completion, expected average of 6 years]
- Cardiovascular death [Time frame: 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]
- Myocardial infarction [Time frame: Through study completion, expected average of 6 years]
- Stroke [Time frame: Through study completion, expected average of 6 years]
- Myocardial revascularization (not related to MI) [Time frame: 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]
- hospital admission because of atrial fibrillation as a primary ICD diagnosis. [Time frame: Through study completion, expected average of 6 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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
Identifiers
NCT: NCT06346145 · MIMS study · 2023-00453