Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Bariatric Surgery
• Intervention / Treatment: Procedure: LSG; Procedure: RYGB

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Obese patients with hypertension

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Rongchong Huang, M.D., Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 1, 2022
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: December 12, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Echocardiography; Cardiac Function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2020-P2-254-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No