Bariatric SurgeryNCT05166954
Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension
An observational study of Bariatric Surgery and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Bariatric Surgery, Hypertension
- What is being tested?
- LSG and RYGB
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Obese patients with hypertension
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Rongchong Huang, M.D., +86-13811039417, rchuang@ccmu.edu.cn
Rongchong Huang, M.D.
About this study
The purpose of this study is to investigate the effect of bariatric surgery on cardiac function assessed by echocardiography in patients with hypertension.
Read the 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.
- Conditions
- Bariatric Surgery, Hypertension
- Being tested
- LSG, RYGB
- Keywords
- Cardiac Function, Echocardiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSGProcedure or surgery
Laparoscopic sleeve gastrectomy (LSG) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.
RYGBProcedure or surgery
Roux-en-Y gastric bypass (LRYGB) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia.
| Study group | Role | What they receive |
|---|---|---|
| LSG group | Laparoscopic sleeve gastrectomy (LSG) performed as a treatment for obesity Receives: Procedure: LSG | |
| RYGB group | Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity Receives: Procedure: RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on left ventricular ejection fraction (LVEF)
Changes on LVEF in % assessed with the use of transthoracic echocardiography (TTE).
Measured: 12 months
Secondary outcomes (9)
Changes on left ventricular ejection fraction (LVEF)
Changes on LVEF in % assessed with the use of TTE.
Measured: 24 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Changes on LVEDD in mm assessed with the use of TTE.
Measured: 12 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Changes on LVEDD in mm assessed with the use of TTE.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Changes on blood pressure
Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.
Measured: 12 months
Changes on blood pressure
Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Aug 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rongchong Huang, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166954
- Sponsor's protocol ID
- 2020-P2-254-02
- Status last verified
- Feb 2025
- First submitted
- 12 Dec 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Cardiac Function in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05166954
- Acronym / sponsor ID
- 2020-P2-254-02
- Conditions
- Bariatric Surgery, Hypertension
- Keywords
- Cardiac Function, Echocardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG group | – | Procedure: LSGLaparoscopic sleeve gastrectomy (LSG) performed as a treatment for obesity |
| RYGB group | – | Procedure: RYGBLaparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obese patients with hypertension
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSGLaparoscopic sleeve gastrectomy (LSG) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia. | Procedure or surgery | LSG group |
| RYGBRoux-en-Y gastric bypass (LRYGB) together with medical treatment aiming the control of cardiovascular risks including hypertension, diabetes mellitus or dyslipidemia. | Procedure or surgery | RYGB group |
Primary outcome
Changes on left ventricular ejection fraction (LVEF)
Time frame: 12 months
Changes on LVEF in % assessed with the use of transthoracic echocardiography (TTE).
9 secondary outcomes
Changes on left ventricular ejection fraction (LVEF)
Time frame: 24 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Time frame: 12 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Time frame: 24 months
Major adverse cardiac events
Time frame: 12 months
Major adverse cardiac events
Time frame: 24 months
Changes on number of antihypertensive drugs
Time frame: 12 months
Changes on number of antihypertensive drugs
Time frame: 24 months
Changes on blood pressure
Time frame: 12 months
Changes on blood pressure
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rongchong Huang, M.D. principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongchong Huang, M.D. (+86-13811039417, rchuang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on left ventricular ejection fraction (LVEF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.