Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

NCT06346145 | Not Yet Recruiting DMC

• 2 other identifiers: MIMS study2023-00453
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity, Morbid; Bariatric Surgery Candidate; Heart Diseases

Outcome Measures

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.

  Through study completion, expected average of 6 years

Secondary Outcomes (9)

• Total event rate

  Through study completion, expected average of 6 years

• All-cause mortality

  Through study completion, expected average of 6 years

• Cardiovascular death

  Through study completion, expected average of 6 years

• Remission of type 2 diabetes (T2D) and hypertension

  Through study completion, expected average of 6 years

• Myocardial infarction

  Through study completion, expected average of 6 years

Other Outcomes (5)

• 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.

  Through study completion, expected average of 6 years

• Body weight change

  5-year follow-up

• Change in quality of life

  5-year follow-up

Study Arms (2)

Bariatric surgery

ACTIVE COMPARATOR

Gastric bypass or gastric sleeve

Procedure: Bariatric surgery

Standard care

ACTIVE COMPARATOR

Standard obesity treatment offered in Swedish regions

Procedure: Standard care

Interventions

Bariatric surgery PROCEDURE

Type of surgery assigned by surgeon in consultation with patient

Bariatric surgery

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.

Standard care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥35 kg/m2
• Written informed consent obtained

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator
• The 21 healthcare regions in Sweden: collaborator

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Heart Diseases

Interventions

Bariatric Surgery; Standard of Care

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Erik Näslund, MD, PhD

  Karolinska Institutet/Danderyd hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Näslund, MD, PhD

CONTACT

46812355017; Erik.Naslund@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share