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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes on left ventricular ejection fraction (LVEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension
- •18-70 years old
- •No major barriers to provide written consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sacubitril / Valsartan Oral Tablet [Entresto] (Drug)
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.
干预措施: ACEI/ARB (Drug)
结局指标
主要结局
Changes on left ventricular ejection fraction (LVEF)
时间窗: 6 months
Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).
次要结局
- Changes on cardiac systolic function(6 months)
- Changes on left ventricular end-systolic diameter (LVESD)(6 months)
- Changes on hypertension-mediated target organ damage(12 months)
- Major adverse cardiac events(12 months)
- Changes on left ventricular end-diastolic diameter (LVEDD)(6 months)
- Changes on blood pressure(12 months)