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

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

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.

Study Overview

• Status: Unknown
• Conditions: Essential Hypertension
• Intervention / Treatment: Device: Stendo pulsating suit System

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guy AMAH, MD; Phone Number: +331 49 95 80 88; Email: guy.amah@lrb.aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles
    • Contact: Guy AMAH, MD; Phone Number: +33 1 49 95 80 88; Email: guy.amah@lrb.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stendo
• Investigators: Principal Investigator: Guy AMAH, MD, Service de Physiologie Clinique - Explorations Fonctionnelles

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ANTICIPATED): July 1, 2015
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (ESTIMATE): October 29, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Essential Hypertension; Microcirculation; Central Blood Pressure; Endothelium Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: 2014-A00804-43