Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sacubitril/valsartan group 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]
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 group 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Changes on left ventricular end-systolic diameter (LVESD) [6 months]
Changes on LVESD in mm assessed with the use of CMR.
- Changes on left ventricular end-diastolic diameter (LVEDD) [6 months]
Changes on LVEDD in mm assessed with the use of CMR.
- 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.
- Major adverse cardiac events [6 months]
Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.
- 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 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
- Changes on blood pressure [6 months]
Changes on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM).
- Changes on blood pressure [12 months]
Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with essential hypertension
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18-70 years old
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No major barriers to provide written consent
Exclusion Criteria:
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Secondary hypertension, except because of sleep apnea
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cardiovascular disease (myocardial infarction, heart failure, stroke or coronary revascularization) within 6 months
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Severe concomitant diseases (autoimmune disease, malignancy, late stage of liver diseases, respiratory diseases and digestive diseases)
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Unable to understand or comply with the study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing | China | 100050 |
Sponsors and Collaborators
- Beijing Friendship Hospital
Investigators
- Principal Investigator: Rongchong Huang, M.D., Beijing Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-P2-173-01