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Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study

Effect of Sacubitril/Valsartan on Cardiac Function Assessed by Cardiac Magnetic Resonance (CMR) in Hypertensive Patients Stratified by Body Mass Index (BMI): A Real World Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05498675
Enrollment
180
Registered
2022-08-12
Start date
2021-09-01
Completion date
2027-06-30
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacubitril/Valsartan, Hypertension, Obesity

Keywords

Cardiac function, Cardiac magnetic resonance

Brief summary

The purpose of this study is to investigate the effect of sacubitril/valsartan on cardiac function assessed by cardiac magnetic resonance (CMR) in hypertensive patients stratified by BMI.

Detailed description

Obesity is one of the risk factors of hypertension, and affects cardiac structure and function in the long term for hypertensive patients. Sacubitril/valsartan is regarded as a better antihypertensive drug for the improvement of cardiac function for patients with heart failure, but it remains unclear whether there are differences among different BMI groups. Therefore, the aim of this study was to evaluate the benefit of sacubitril/valsartan versus other antihypertensive drugs on cardiac structure and function assessed by CMR in hypertensive patients stratified by BMI in the real world.

Interventions

There is no treatment allocation. Patients administered sacubitril / valsartan oral tablet (Entresto) 200mg 1/day by prescription that have started before inclusion of the patient enrolled into the study and defined as sacubitril/valsartan group.

There is no treatment allocation. Patients administered angiotensin-converting enzyme inhibitors/angiotensin II receptor antagonists (ACEI/ARB) by prescription that have started before inclusion of the patient enrolled into the study and defined as ACEI/ARB group. Including: benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan.

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients with essential hypertension * 18-70 years old * 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

Design outcomes

Primary

MeasureTime frameDescription
Changes on left ventricular ejection fraction (LVEF)6 monthsChanges on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).

Secondary

MeasureTime frameDescription
Changes on left ventricular end-diastolic diameter (LVEDD)6 monthsChanges on LVEDD in mm assessed with the use of CMR.
Changes on cardiac systolic function6 monthsChanges on cardiac systolic function in E/A, E-wave deceleration time (EDT) in ms assessed with the use of CMR.
Changes on left ventricular end-systolic diameter (LVESD)6 monthsChanges on LVESD in mm assessed with the use of CMR.
Changes on hypertension-mediated target organ damage12 monthsChange on hypertension-mediated target organ damage including the estimated glomerular filtration rate (eGFR), total cholesterol, triglycerides level, LDL-cholesterol, HDL-cholesterol, and carotid intima-media thickness (IMT) assessed by carotid ultrasound
Changes on blood pressure6 monthsChanges on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM).
Major adverse cardiac events6 monthsIncluding all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.

Countries

China

Contacts

Primary ContactRongchong Huang, M.D.
rchuang@ccmu.edu.cn+86-13811039417

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026