Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Central Blood Pressure in Essential Hypertension Patients Treated But Not Stabilized
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peripheral microcirculation measured using Laser Doppler flowmetry
研究概览
简要总结
The action of one Stendo pulsating suit session will be evaluated on 24 patients referred to the hypertension consultations for essential hypertension treated but not stabilized. The effect of one Stendo pulsating suit session system will be mainly assessed on the peripheral cutaneous microcirculation and on the central arterial pressure.
详细描述
The role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibres. The release of these products is modulated, in turn, by various circulating molecules, by the autonomic nervous system and by local mechanical factors such as shear stress.
The essential hypertension is associated to increased risks of cardiovascular and stroke morbidity and mortality and constitutes a major cause of severe kidney failure. The essential hypertension is a complex and multi-factorial disease; the dysfunction of the endothelium is of a great importance in the physiopathology of this disease, concerning both the consequences of the increase of the blood pressure and the possible cause of the hypertension development.
The Stendo pulsating suit is expected to increase the cutaneous microcirculation measured by laser Doppler laser flowmetry and potentially to decrease the central blood pressure. Each patient will be his own witness and the clinical records will be assessed before, during when relevant, and after a pulsating suit session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient referred to the Hypertension Hospital Consultation for essential hypertension treated but not stabilized
- •Patient with essential hypertension defined by a brachial arterial pressure of 140 ≤ Systolic Arterial Pressure < 180 mm Hg and/or 90 ≤ Diastolic Arterial - Pressure < 110 mm Hg
- •Essential Hypertension confirmed by an ambulatory measure of the arterial pressure during 24 hours before the pre-inclusion visit
- •Patients aged more than 40 and less than 70
排除标准
- •Patient with secondary hypertension
- •Patient with diabetes
- •Patient with complete arrhythmia with atrial fibrillation
- •Patient with an advanced obstructive arterial disease
- •Patient with a recent and progressive deep venous thrombosis
研究组 & 干预措施
Stendo pulsating suit System
One 20 minutes Stendo pulsating suit session will be applied to the patient.
干预措施: Stendo pulsating suit System (Device)
结局指标
主要结局
Peripheral microcirculation measured using Laser Doppler flowmetry
时间窗: 35 minutes after the end of the Stendo session at D1 + 7 jours +/- 3
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
次要结局
- Humeral arterial pressure(20 minutes after the end of Stendo session at D1 + 7 jours +/- 3)
- Central blood pressure(Just after the end of the Stendo session.at D1 + 7 jours +/- 3)