Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension

NCT05166954 | Recruiting

• 1 other identifier: 2020-P2-254-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery; Hypertension

Keywords

Cardiac Function; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Changes on left ventricular ejection fraction (LVEF)

  Changes on LVEF in % assessed with the use of transthoracic echocardiography (TTE).

  12 months

Secondary Outcomes (9)

• Changes on left ventricular ejection fraction (LVEF)

  24 months

• Changes on left ventricular end-diastolic diameter (LVEDD)

  12 months

• Changes on left ventricular end-diastolic diameter (LVEDD)

  24 months

• Major adverse cardiac events

  12 months

• Major adverse cardiac events

  24 months

Study Arms (2)

LSG group

Laparoscopic sleeve gastrectomy (LSG) performed as a treatment for obesity

Procedure: LSG

RYGB group

Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity

Procedure: RYGB

Interventions

LSG PROCEDURE

Laparoscopic sleeve gastrectomy (LSG) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.

LSG group

RYGB PROCEDURE

Roux-en-Y gastric bypass (LRYGB) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.

RYGB group

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients with hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rongchong Huang, M.D.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongchong Huang, M.D.

CONTACT

+86-13811039417; rchuang@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 22, 2021
• Study Start: August 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)