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

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stendo pulsating suit System
Sponsored by
Stendo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential Hypertension, Central Blood Pressure, Microcirculation, Endothelium Stimulation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Lariboisière - Service de Physiologie Clinique - Explorations FonctionnellesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stendo pulsating suit System

Arm Description

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

Outcomes

Primary Outcome Measures

Peripheral microcirculation measured using Laser Doppler flowmetry
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session

Secondary Outcome Measures

Humeral arterial pressure
Humeral arterial pressure using automatic measures with Dinamap device
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.

Full Information

First Posted
October 8, 2014
Last Updated
May 21, 2015
Sponsor
Stendo
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1. Study Identification

Unique Protocol Identification Number
NCT02277821
Brief Title
Evaluation of Stendo Pulsating Suit on Microcirculation and Central Blood Pressure in Essential Hypertension Patients
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stendo

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential Hypertension, Central Blood Pressure, Microcirculation, Endothelium Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stendo pulsating suit System
Arm Type
Experimental
Arm Description
One 20 minutes Stendo pulsating suit session will be applied to the patient.
Intervention Type
Device
Intervention Name(s)
Stendo pulsating suit System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Peripheral microcirculation measured using Laser Doppler flowmetry
Description
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
Time Frame
35 minutes after the end of the Stendo session at D1 + 7 jours +/- 3
Secondary Outcome Measure Information:
Title
Humeral arterial pressure
Description
Humeral arterial pressure using automatic measures with Dinamap device
Time Frame
20 minutes after the end of Stendo session at D1 + 7 jours +/- 3
Title
Central blood pressure
Description
Central blood pressure measured by applanation using an applanation tonometry device; Central pulse pressure, Augmentation Index and subendocardial viability ratio will also be assessed.
Time Frame
Just after the end of the Stendo session.at D1 + 7 jours +/- 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy AMAH, MD
Phone
+331 49 95 80 88
Email
guy.amah@lrb.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy AMAH, MD
Organizational Affiliation
Service de Physiologie Clinique - Explorations Fonctionnelles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy AMAH, MD
Phone
+33 1 49 95 80 88
Email
guy.amah@lrb.aphp.fr

12. IPD Sharing Statement

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

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