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

Recruiting

• Conditions: Sacubitril/valsartan; Hypertension; Obesity
• Interventions: Drug: ACEI/ARB; Drug: Sacubitril / Valsartan Oral Tablet [Entresto]

• Registration Number: NCT05498675
• Lead Sponsor: Beijing Friendship Hospital

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACEI/ARB group	ACEI/ARB	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.
Sacubitril/valsartan group	Sacubitril / Valsartan Oral Tablet [Entresto]	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.

Primary Outcome Measures

Name	Time	Method
Changes on left ventricular ejection fraction (LVEF)	6 months	Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).

Secondary Outcome Measures

Name	Time	Method
Changes on cardiac systolic function	6 months	Changes 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 months	Changes on LVESD in mm assessed with the use of CMR.
Changes on hypertension-mediated target organ damage	12 months	Change 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
Major adverse cardiac events	12 months	Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.
Changes on left ventricular end-diastolic diameter (LVEDD)	6 months	Changes on LVEDD in mm assessed with the use of CMR.
Changes on blood pressure	12 months	Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China