Evaluation of Stendo Pulsating Suit on Microcirculation and Central Blood Pressure in Essential Hypertension Patients

Sponsor

Stendo (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02277821

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Device: Stendo pulsating suit System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Peripheral microcirculation measured using Laser Doppler flowmetry [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

Secondary Outcome Measures

Humeral arterial pressure [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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