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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277821
• Other study ID #: 2014-A00804-43
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2014
• Last updated: May 21, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2014
• Source: Stendo
• Contact: Guy AMAH, MD
• Phone: +331 49 95 80 88
• Email: guy.amah[@]lrb.aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Stendo

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral microcirculation measured using Laser Doppler flowmetry	Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session	35 minutes after the end of the Stendo session at D1 + 7 jours +/- 3	No
Secondary	Humeral arterial pressure	Humeral arterial pressure using automatic measures with Dinamap device	20 minutes after the end of Stendo session at D1 + 7 jours +/- 3	No
Secondary	Central blood pressure	Central blood pressure measured by applanation using an applanation tonometry device; Central pulse pressure, Augmentation Index and subendocardial viability ratio will also be assessed.	Just after the end of the Stendo session.at D1 + 7 jours +/- 3	No