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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sacubitril/Valsartan, Hypertension, Obesity

Intervention / Treatment
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* Drug: Sacubitril / Valsartan Oral Tablet [Entresto]
* Drug: ACEI/ARB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sacubitril/valsartan group<br>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. | Drug: Sacubitril / Valsartan Oral Tablet [Entresto]<br>* 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.<br>|
| ACEI/ARB group<br>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. | Drug: ACEI/ARB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on left ventricular ejection fraction (LVEF) | Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on left ventricular end-systolic diameter (LVESD) | Changes on LVESD in mm assessed with the use of CMR. | 6 months | 
| Changes on left ventricular end-diastolic diameter (LVEDD) | Changes on LVEDD in mm assessed with the use of CMR. | 6 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Changes on blood pressure | Changes on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM). | 6 months | 
| Changes on blood pressure | Changes on systolic and blood pressure assessed with the use of 24-hour ABPM. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac function, Cardiac magnetic resonance