Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Bariatric surgery
  Type of surgery assigned by surgeon in consultation with patient
• Процедура 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.

Первичные конечные точки

• 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. [Срок оценки: Through study completion, expected average of 6 years]

Вторичные конечные точки (9)

• Total event rate [Срок оценки: Through study completion, expected average of 6 years]
• All-cause mortality [Срок оценки: Through study completion, expected average of 6 years]
• Cardiovascular death [Срок оценки: Through study completion, expected average of 6 years]
• Remission of type 2 diabetes (T2D) and hypertension [Срок оценки: Through study completion, expected average of 6 years]
• Myocardial infarction [Срок оценки: Through study completion, expected average of 6 years]
• Stroke [Срок оценки: Through study completion, expected average of 6 years]
• Myocardial revascularization (not related to MI) [Срок оценки: Through study completion, expected average of 6 years]
• hospital admission because of heart failure as a primary ICD diagnosis. [Срок оценки: Through study completion, expected average of 6 years]
• hospital admission because of atrial fibrillation as a primary ICD diagnosis. [Срок оценки: Through study completion, expected average of 6 years]

Критерии участия

Критерии включения

• MI (as defined by the universal definition of MI) at least 1 year before inclusion.
• BMI ≥35 kg/m2
• Written informed consent obtained

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06346145 · MIMS study · 2023-00453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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