NCT06346145Not yet recruiting
Impact of Bariatric Surgery on Heart Disease Compared to Standard Care
A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 15 Mar 2024
- Start date
- 1 May 2024
- Primary completion date
- 1 May 2028
- Lead sponsor
- Danderyd Hospital
- Diseases
- Obesity
- NCT number
- NCT06346145
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 May 2024 to the primary completion date, 1 May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Unable to understand Swedish.
Who the study is looking for
- MI (as defined by the universal definition of MI) at least 1 year before inclusion.
- BMI ≥35 kg/m2
- Written informed consent obtained
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.