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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMay 22, 2015
October 1, 2014
9 months
October 8, 2014
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Humeral arterial pressure
20 minutes after the end of Stendo session at D1 + 7 jours +/- 3
Central blood pressure
Just after the end of the Stendo session.at D1 + 7 jours +/- 3
Study Arms (1)
Stendo pulsating suit System
EXPERIMENTALOne 20 minutes Stendo pulsating suit session will be applied to the patient.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
- Patients aged more than 40 and less than 70
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stendolead
Study Sites (1)
Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles
Paris, 75010, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy AMAH, MD
Service de Physiologie Clinique - Explorations Fonctionnelles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 29, 2014
Study Start
October 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
May 22, 2015
Record last verified: 2014-10