Clinical trial NCT05166954: Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension
Official title: Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Hypertension
Keywords: Cardiac Function
Echocardiography
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with hypertension

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes on left ventricular ejection fraction (LVEF)
timeFrame: 12 months
Secondary outcomes:
measure: Changes on left ventricular ejection fraction (LVEF)
timeFrame: 24 months
measure: Changes on left ventricular end-diastolic diameter (LVEDD)
timeFrame: 12 months
measure: Changes on left ventricular end-diastolic diameter (LVEDD)
timeFrame: 24 months
measure: Major adverse cardiac events
timeFrame: 12 months
measure: Major adverse cardiac events
timeFrame: 24 months
measure: Changes on number of antihypertensive drugs
timeFrame: 12 months
measure: Changes on number of antihypertensive drugs
timeFrame: 24 months
measure: Changes on blood pressure
timeFrame: 12 months
measure: Changes on blood pressure
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Rongchong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: