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

NCT ID: NCT02277821

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-07-31

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stendo pulsating suit System

One 20 minutes Stendo pulsating suit session will be applied to the patient.

Group Type: EXPERIMENTAL

Stendo pulsating suit System

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stendo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy AMAH, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Physiologie Clinique - Explorations Fonctionnelles

Locations

Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guy AMAH, MD

Role: CONTACT

guy.amah@lrb.aphp.fr

+331 49 95 80 88

Facility Contacts

Guy AMAH, MD

Role: primary

guy.amah@lrb.aphp.fr

+33 1 49 95 80 88

Other Identifiers

2014-A00804-43

Identifier Type: -

Identifier Source: org_study_id