Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension

Conditions
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Bariatric Surgery, Hypertension

Intervention / Treatment
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* Procedure: LSG
* Procedure: RYGB


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSG group<br>Laparoscopic sleeve gastrectomy (LSG) performed as a treatment for obesity | Procedure: LSG<br>* Laparoscopic sleeve gastrectomy (LSG) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.<br>|
| RYGB group<br>Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity | Procedure: RYGB<br>* Roux-en-Y gastric bypass (LRYGB) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on left ventricular ejection fraction (LVEF) | Changes on LVEF in % assessed with the use of transthoracic echocardiography (TTE). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on left ventricular ejection fraction (LVEF) | Changes on LVEF in % assessed with the use of TTE. | 24 months | 
| Changes on left ventricular end-diastolic diameter (LVEDD) | Changes on LVEDD in mm assessed with the use of TTE. | 12 months | 
| Changes on left ventricular end-diastolic diameter (LVEDD) | Changes on LVEDD in mm assessed with the use of TTE. | 24 months | 
| Major adverse cardiac events | including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery. | 12 months | 
| Major adverse cardiac events | including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery. | 24 months | 
| Changes on number of antihypertensive drugs | 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. | 12 months | 
| Changes on number of antihypertensive drugs | 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. | 24 months | 
| Changes on blood pressure | Changes on systolic and blood pressure assessed with the use of 24-hour ABPM. | 12 months | 
| Changes on blood pressure | Changes on systolic and blood pressure assessed with the use of 24-hour ABPM. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Function, Echocardiography