Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Emerging atrial fibrillation
研究概览
简要总结
The investigators want to explore the relationship between different configurations of hypertension and the incidence of cardiovascular events by the guidelines reference range and EMINCA recommended reference range. Then the investigators want to enroll twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up. Echocardiographic measurement parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.
详细描述
Different configurations of hypertension are important risk factor for the morbidity and mortality of cardiovascular and cerebrovascular diseases in China. Studies have shown that left ventricular hypertrophy (LVH) and left atrial enlargement caused by hypertension are independent risk factors for cardiovascular events. The LVM and LAV derived from the normal value data of Chinese healthy adults have been reported to be different from the recommended reference values in guidelines, and the distribution characteristics of hypertension remodeling are also different. However, the characteristics and outcomes of cardiac remodeling in Chinese hypertensive population and whether this difference in configuration has an impact on the treatment, prognosis and cardiovascular events of hypertensive population are still needed to be explored.
This study was to observe the relationship between blood pressure and cardiovascular remodeling evaluated by different standards in hypertensive population, and compare the relationship between different cardiac configurations and cardiovascular events in Chinese hypertensive population.
Twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up.
Echocardiographic measurement parameters including M-mode and two-dimensional ultrasonic parameters; doppler ultrasound parameters; relevant parameters of two-dimensional speckle tracking, myocardial work parameters; the left ventricular remodeling parameters (LVM and RWT); cardiac morphological changes; three-dimensional ultrasound parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-75 years old;
- •No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg;
- •Left ventricular ejection fraction was normal (LVEF ≥ 0.5).
- •All patients agreed to participate in the experiment and signed the informed consent form.
排除标准
- •Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases;
- •Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery;
- •Abnormal liver function; abnormal renal function and diabetes;
- •Pregnant or breastfeeding women;
- •Expected survival time due to non-cardiovascular disease<4 years;
- •Patients with poor echocardiographic image quality.
结局指标
主要结局
Emerging atrial fibrillation
时间窗: Through study completion, on average once a year.
The differences in the incidence of atrial fibrillation between the two groups
Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death
时间窗: Through study completion, on average once a year.
The differences in the incidence of unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death between the two groups
Emerging transient ischemic attack (TIA) or stroke
时间窗: Through study completion, on average once a year.
The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups
次要结局
- Emerging decreased cardiac function with preserved ejection fraction(Through study completion, on average once a year.)
- Emerging aortic aneurysm or aortic dissection(Through study completion, on average once a year.)
- Emerging serious arrhythmias(Through study completion, on average once a year.)
- The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexes(Through study completion, on average once a year.)
- Emerging cardiac remodeling(Through study completion, on average once a year.)