Essential HypertensionNCT02277821
Evaluation of Stendo Pulsating Suit on Microcirculation and Central Blood Pressure in Essential Hypertension Patients
A study testing Stendo pulsating suit System in people with Essential Hypertension, run by Stendo at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Stendo pulsating suit System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles
Paris, 75010
Guy AMAH, MD, +33 1 49 95 80 88, guy.amah@lrb.aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Stendo pulsating suit System
- Keywords
- Essential Hypertension, Central Blood Pressure, Microcirculation, Endothelium Stimulation
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stendo pulsating suit SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Stendo pulsating suit System | Experimental | One 20 minutes Stendo pulsating suit session will be applied to the patient. Receives: Device: Stendo pulsating suit System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral microcirculation measured using Laser Doppler flowmetry
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
Measured: 35 minutes after the end of the Stendo session at D1 + 7 jours +/- 3
Secondary outcomes (2)
Humeral arterial pressure
Humeral arterial pressure using automatic measures with Dinamap device
Measured: 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.
Measured: Just after the end of the Stendo session.at D1 + 7 jours +/- 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stendo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy AMAH, MD, Principal investigator, Service de Physiologie Clinique - Explorations Fonctionnelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277821
- Sponsor's protocol ID
- 2014-A00804-43
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02277821
- Acronym / sponsor ID
- 2014-A00804-43
- Conditions
- Essential Hypertension
- Keywords
- Essential Hypertension, Central Blood Pressure, Microcirculation, Endothelium Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- StendoIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stendo pulsating suit System | Experimental | Device: Stendo pulsating suit SystemOne 20 minutes Stendo pulsating suit session will be applied to the patient. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stendo pulsating suit SystemThe 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). | Device | Stendo pulsating suit System |
Primary outcome
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
2 secondary outcomes
Humeral arterial pressure
Time frame: 20 minutes after the end of Stendo session at D1 + 7 jours +/- 3
Central blood pressure
Time frame: Just after the end of the Stendo session.at D1 + 7 jours +/- 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy AMAH, MD principal investigator
Service de Physiologie Clinique - Explorations Fonctionnelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stendo pulsating suit System in people with Essential Hypertension, run by Stendo at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy AMAH, MD (+331 49 95 80 88, guy.amah@lrb.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral microcirculation measured using Laser Doppler flowmetry (time frame: 35 minutes after the end of the Stendo session at D1 + 7 jours +/- 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.