Evaluation of Stendo Pulsating Suit on Microcirculation and Central Blood Pressure in Essential Hypertension Patients
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|ClinicalTrials.gov Identifier: NCT02277821|
Recruitment Status : Unknown
Verified October 2014 by Stendo.
Recruitment status was: Recruiting
First Posted : October 29, 2014
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Device: Stendo pulsating suit System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Experimental: Stendo pulsating suit System
One 20 minutes Stendo pulsating suit session will be applied to the patient.
Device: Stendo pulsating suit System
The Stendo system, a multilayer pulsatile inflatable suit is applied to the lower limbs and the abdomen. This device induces a sequential compartmentalized compression synchronized with each diastolic phase of the cardiac cycle, each phase evolving centripetally (lower limbs to abdomen).
- Peripheral microcirculation measured using Laser Doppler flowmetry [ Time Frame: 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
- Humeral arterial pressure [ Time Frame: 20 minutes after the end of Stendo session at D1 + 7 jours +/- 3 ]Humeral arterial pressure using automatic measures with Dinamap device
- Central blood pressure [ Time Frame: Just after the end of the Stendo session.at D1 + 7 jours +/- 3 ]Central blood pressure measured by applanation using an applanation tonometry device; Central pulse pressure, Augmentation Index and subendocardial viability ratio will also be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277821
|Contact: Guy AMAH, MD||+331 49 95 80 firstname.lastname@example.org|
|Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles||Recruiting|
|Paris, France, 75010|
|Contact: Guy AMAH, MD +33 1 49 95 80 88 email@example.com|
|Principal Investigator:||Guy AMAH, MD||Service de Physiologie Clinique - Explorations Fonctionnelles|