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

• ClinicalTrials.gov Identifier: NCT02277821
• Recruitment Status: Unknown
• First Posted: October 29, 2014
• Last Update Posted: May 22, 2015
• Sponsor: Stendo
• Information provided by (Responsible Party): Stendo

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	Not Applicable

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 (Clinical Trial)
• Estimated 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: October 2014
• Estimated Primary Completion Date: July 2015
• Estimated Study Completion Date: July 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).

Outcome Measures

Primary Outcome Measures :

1. Peripheral microcirculation measured using Laser Doppler flowmetry [ Time Frame: 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 :

1. Humeral arterial pressure [ Time Frame: 20 minutes after the end of Stendo session at D1 + 7 jours +/- 3 ]
   Humeral arterial pressure using automatic measures with Dinamap device
2. Central blood pressure [ Time Frame: 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

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Guy AMAH, MD; +331 49 95 80 88; guy.amah@lrb.aphp.fr

Locations

France

Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles; Recruiting

Paris, France, 75010

Contact: Guy AMAH, MD +33 1 49 95 80 88 guy.amah@lrb.aphp.fr

Sponsors and Collaborators

Stendo

Investigators

• Principal Investigator: Guy AMAH, MD; Service de Physiologie Clinique - Explorations Fonctionnelles

More Information

• Responsible Party: Stendo
• ClinicalTrials.gov Identifier: NCT02277821
• Other Study ID Numbers: 2014-A00804-43
• First Posted: October 29, 2014
• Last Update Posted: May 22, 2015
• Last Verified: October 2014

Keywords provided by Stendo:

Essential Hypertension; Central Blood Pressure; Microcirculation; Endothelium Stimulation

Additional relevant MeSH terms:

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases