Clinical trial NCT02277821: Evaluation of Stendo Pulsating Suit on Microcirculation and Central Blood Pressure in Essential Hypertension Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Central Blood Pressure
Microcirculation
Endothelium Stimulation
Lead sponsor: Stendo
Sponsor class: INDUSTRY
First posted: 2014-10-29
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Peripheral microcirculation measured using Laser Doppler flowmetry
timeFrame: 35 minutes after the end of the Stendo session at D1 + 7 jours +/- 3
Secondary outcomes:
measure: Humeral arterial pressure
timeFrame: 20 minutes after the end of Stendo session at D1 + 7 jours +/- 3
measure: Central blood pressure
timeFrame: Just after the end of the Stendo session.at D1 + 7 jours +/- 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles
Study officials:
affiliation: Service de Physiologie Clinique - Explorations Fonctionnelles
name: Guy AMAH, MD
role: PRINCIPAL_INVESTIGATOR
References: