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NCT Number: NCT05166954

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.

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Key information

Conditions

Bariatric Surgery Cardiovascular Diseases Hypertension Vascular Diseases

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Rongchong Huang, M.D.

CONTACT

[email protected]

+86-13811039417

Rongchong Huang, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LSG

Procedure

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

RYGB

Procedure

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

Primary outcomes

  1. Changes on left ventricular ejection fraction (LVEF)

    Time frame: 12 months

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

Secondary outcomes

  1. Changes on left ventricular ejection fraction (LVEF)

    Time frame: 24 months

    Changes on LVEF in % assessed with the use of TTE.

  2. Changes on left ventricular end-diastolic diameter (LVEDD)

    Time frame: 12 months

    Changes on LVEDD in mm assessed with the use of TTE.

  3. Changes on left ventricular end-diastolic diameter (LVEDD)

    Time frame: 24 months

    Changes on LVEDD in mm assessed with the use of TTE.

  4. Major adverse cardiac events

    Time frame: 12 months

    including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.

  5. Major adverse cardiac events

    Time frame: 24 months

    including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.

  6. Changes on number of antihypertensive drugs

    Time frame: 12 months

    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.

  7. Changes on number of antihypertensive drugs

    Time frame: 24 months

    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.

  8. Changes on blood pressure

    Time frame: 12 months

    Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.

  9. Changes on blood pressure

    Time frame: 24 months

    Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.

Study contacts

Contact information is provided by the study sponsor or research team.

Rongchong Huang, M.D.

CONTACT

[email protected]

+86-13811039417

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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