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NCT05166954 Clinical Trial

Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05166954
Other study ID # 2020-P2-254-02
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date October 1, 2023

Study information
Verified date August 2023
Source Beijing Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date October 1, 2023
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 17 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• LSG
Laparoscopic sleeve gastrectomy (LSG) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.
• RYGB
Roux-en-Y gastric bypass (LRYGB) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.

Locations
Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes on left ventricular ejection fraction (LVEF) Changes on LVEF in % assessed with the use of transthoracic echocardiography (TTE). 12 months
Secondary Changes on left ventricular ejection fraction (LVEF) Changes on LVEF in % assessed with the use of TTE. 24 months
Secondary Changes on left ventricular end-diastolic diameter (LVEDD) Changes on LVEDD in mm assessed with the use of TTE. 12 months
Secondary Changes on left ventricular end-diastolic diameter (LVEDD) Changes on LVEDD in mm assessed with the use of TTE. 24 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Changes on blood pressure Changes on systolic and blood pressure assessed with the use of 24-hour ABPM. 12 months
Secondary Changes on blood pressure Changes on systolic and blood pressure assessed with the use of 24-hour ABPM. 24 months
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