Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension

Active, not recruiting

• Conditions: Hypertension; Bariatric Surgery
• Interventions: Procedure: LSG; Procedure: RYGB

• Registration Number: NCT05166954
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

The purpose of this study is to investigate the effect of bariatric surgery on cardiac function assessed by echocardiography in patients with hypertension.

Detailed Description

Obesity is the most common chronic metabolic disease worldwide, causing the increasing burden of cardiovascular risk factors such as hypertension, and affecting cardiac structure and function in the long term. Nowadays, bariatric surgery is regarded as the most effective approach for weight loss, and the only approach for reducing obesity-related cardiovascular events. However, the effect of different bariatric surgeries such as laparoscopic sleeve gastrectomy (LSG) or Roux-en-Y gastric bypass (RYGB) on cardiac function in patients with hypertension is still unclear. Therefore, the aim of this study was to evaluate the benefit of different bariatric surgeries on cardiac structure and function echocardiography in patients with hypertension.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2021-12-12
• Study First Posted: 2021-12-22
• Primary Completion: 2022-08-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18-70 years old
• BMI>24kg/m2
• Bariatric surgery patients of Beijing Friendship Hospital
• History of hypertension and treated with ≥2 antihypertensive drugs for more than 4 weeks
• No major barriers to provide written consent

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Exclusion Criteria

• Secondary hypertension, except because of sleep apnea
• cardiovascular disease (myocardial infarction, heart failure, stroke or coronary revascularization) within 6 months
• Severe concomitant diseases (autoimmune disease, malignancy, late stage of liver diseases, respiratory diseases and digestive diseases)
• Unable to understand or comply with the study procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LSG group	LSG	Laparoscopic sleeve gastrectomy (LSG) performed as a treatment for obesity
RYGB group	RYGB	Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity

Primary Outcome Measures

Name	Time	Method
Changes on left ventricular ejection fraction (LVEF)	12 months	Changes on LVEF in % assessed with the use of transthoracic echocardiography (TTE).

Secondary Outcome Measures

Name	Time	Method
Changes on left ventricular end-diastolic diameter (LVEDD)	24 months	Changes on LVEDD in mm assessed with the use of TTE.
Changes on number of antihypertensive drugs	24 months	Changes on of the total number of antihypertensive medications while maintaining office systolic and diastolic blood pressure \<140 mm Hg and 90 mm Hg, respectively.
Changes on left ventricular ejection fraction (LVEF)	24 months	Changes on LVEF in % assessed with the use of TTE.
Major adverse cardiac events	24 months	including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.
Changes on blood pressure	24 months	Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China