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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Stendo.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stendo
ClinicalTrials.gov Identifier:
NCT02277821
First received: October 8, 2014
Last updated: May 21, 2015
Last verified: October 2014
  Purpose
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 Intervention
Essential Hypertension
Device: Stendo pulsating suit System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Stendo:

Primary Outcome Measures:
  • 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:
  • 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

  • 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.


Estimated Enrollment: 24
Study Start Date: October 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02277821

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     History of Changes
Other Study ID Numbers: 2014-A00804-43
Study First Received: October 8, 2014
Last Updated: May 21, 2015

Keywords provided by Stendo:
Essential Hypertension
Central Blood Pressure
Microcirculation
Endothelium Stimulation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 24, 2017