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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498675
• Other study ID #: 2022-P2-173-01
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: Beijing Friendship Hospital
• Contact: Rongchong Huang, M.D.
• Phone: +86-13811039417
• Email: rchuang[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Sacubitril/Valsartan

Intervention

Drug:
• Sacubitril / Valsartan Oral Tablet [Entresto]
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.
• ACEI/ARB
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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on left ventricular ejection fraction (LVEF)	Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).	6 months
Secondary	Changes on left ventricular end-systolic diameter (LVESD)	Changes on LVESD in mm assessed with the use of CMR.	6 months
Secondary	Changes on left ventricular end-diastolic diameter (LVEDD)	Changes on LVEDD in mm assessed with the use of CMR.	6 months
Secondary	Changes on cardiac systolic function	Changes on cardiac systolic function in E/A, E-wave deceleration time (EDT) in ms assessed with the use of CMR.	6 months
Secondary	Major adverse cardiac events	Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.	6 months
Secondary	Major adverse cardiac events	Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.	12 months
Secondary	Changes on hypertension-mediated target organ damage	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	12 months
Secondary	Changes on blood pressure	Changes on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM).	6 months
Secondary	Changes on blood pressure	Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.	12 months