Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pulse wave velocity
研究概览
简要总结
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.
The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.
The other basic aim of the study is to determine whether there is a difference (>6mmHg) between the two drugs regarding the reduction of the mean 24hour blood pressure and the effect of them on the hemodynamic parameters.
The hemodynamic parameters that will be measured by applanation tonometry are augmentation index, central blood pressure and pulse wave velocity.
The hemodynamic parameters that will be measured by impedance cardiography are cardiac index, thoracic fluid content index, systemic vascular resistance index and others.
详细描述
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.
The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Drug naive patients with 1st or 2nd grade Arterial Hypertension according to the ESH/ESC guidelines 2013
- •The patient has signed the concent form
排除标准
- •Secondary Hypertension
- •3rd grade of Arterial Hypertension
- •Chronic renal failure
- •Diabetes Mellitus
- •Sleep apnea syndrome
- •Chronic or acute inflammatory diseases
- •Stroke, myocardial infarction, angina pectoris in the past 6 months
- •Heart failure
- •Liver disease
- •Neoplasms
- •Pregnancy
- •Valvular Heart disease
- •Heigt < 120cm or > 230cm, Weight <30kg or >155kg
- •Heart Arrhytmias
- •Artificial cardiac pacemaker
- •Hemodymanic unstable patients
研究组 & 干预措施
Olmesartan
ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target
干预措施: Olmesartan (Drug)
Chlorthalidone
Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target
干预措施: Chlorthalidone (Drug)
结局指标
主要结局
Pulse wave velocity
时间窗: 12 weeks
Measured by Sphygmocor devive
次要结局
- Ambulatory blood pressure(12 months)
- Systemic vascular resistance(12 months)
研究者
Maria Pikilidou, MD, MSc, PhD
Post-doctoral researcher
AHEPA University Hospital