Observational Clinical Trial to Assess Irbesartan Alone or in Combination With Amlodipine and Carvedilol Effectiveness in Patients With Hypertension and Left Ventricular Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood pressure measurement
研究概览
简要总结
Arterial hypertension causes adverse effects on the entire cardiovascular system, with effects centrally such as diastolic dysfunction and structural changes of the left ventricle and, peripherally such as endothelial dysfunction and increased thickness of the vessels.
Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further aggravate the prognosis of these patients.
In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed arterial hypertension was 78% for women and 64% for male patients. This population consists from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more comorbidities and probably less compliance with antihypertensive therapy. Finally, at every age the disease and its effects can affect the quality of life of patients.
The main purpose of this study is to investigate the efficacy of antihypertensive therapy (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular system (diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery).
The secondary objective of the study is to monitor the quality of life (Quality of Life - QoL) of patients.
Additionally the investigators will seek the correlation of results with co-morbidities, compliance, and patient age.
详细描述
The scope of this entire study is to examine the patients as follows::
Complete Echocardiographic Study including the index of left ventricular mass and relative wall thickness (RWT), measurement acquired from left parasternal longitudinal axis.
Further assessment will be diastolic function and filling pressures of the left ventricle using all indices of diastolic function that can be applied in patients with preserved ejection fraction according to the relevant guidelines of the European Society of Cardiology .
This will include the tissue velocities of the mitral annulus (lateral, septal and average) and the ratio of early diastolic transmitral speed to early diastolic mitral annulus velocity.
The flow of the right upper pulmonary vein , will be recorded during the reverse wave. The flow in pulmonary veins (average of 3 different measurements) will be recorded additionally. The transmitral A wave duration will also be measured, with the Pulsed Doppler sample volume placed at the level of the mitral annulus (average of 3 different measures). The time difference between the Ar-A (reverse pulmonary venous - transmitral flow A wave) will be calculated .
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Men and Women
- •Patients with hypertension
- •Patients with preserved left ventricular ejection fraction
- •Patients on monotherapy with irbesartan
- •Patients who have not achieved the therapeutic target regulating AP.
排除标准
- •Patients with systolic left ventricular dysfunction
- •Patients with with severe mitral or aortic valve disease
- •Patients with acute coronary or acute aortic syndrome
- •Patients with febrile infectious disease
结局指标
主要结局
Blood pressure measurement
时间窗: 3 months
Irbesartan effectiveness in diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery (IMT).
次要结局
- Quality of Life questionnaire rating(3 months)