Essential Untreated HypertensionNCT01743352
Comparison of Ultrafast Echo With Echotracking
An observational study of Essential Untreated Hypertension and Healthy Volunteers, run by French Cardiology Society at 1 site in France.
Trial summary
The aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Untreated Hypertension, Healthy Volunteers
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Aug 2015
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting Essential untreated hypertension Healthy Volunteers
Who may be able to join
- hypertension,
- essential (WHO workup),
- untreated (> 28 days of treatment interruption, < 6 months of treatment) on insufficiently equilibrated (BP > 140 and/or 90 mmHg)
Who cannot join
- Any concomitant severe disease compromising patient's participation or compliance
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Européen Georges Pompidou / Service de Pharmacologie
Paris, 75015
About this study
Official title: Protocole ULTRAFAST - ECHOTRACKING : Remodelage pariétal et rigidité artérielle Chez l'Hypertendu : Nouvelle étude de Leur Relation Utilisant l'élastographie Par Ultrafast-écho et la séparation Intima/média Par écho-tracking
The aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in hypertensive arteries.
Read the detailed description
Ultrafast ECHO is a new non invasive method for assessing stiffness of living tissues. It takes advantage of very fast imaging technologies (up to 20 000 images/sec) to measure the diffusion of pressure waves in the tissues. This pressure wave can be either natural (blood pressure), or generated by an very short ultrasonic impulsion at a given place. By using both modes, it is possible to have a precise cartography of tissue mechanical properties. This technique is applied to solid tissues such as breast or liver, but not yet currently to hollow tissues such as arteries. The aim of the present study is to compare the values of stiffness obtained with Ultrafast ECHO with the reference non invasive technique, the Echotracking, which measures stiffness by assessing the deformation of arteries in response to changes in blood pressure. On the physiological part, we will revisit old concepts of increased stiffness of hypertensive's arteries. Indeed, hypertension is associated with increased stiffness due to recruitement of collagen fibers, but also to chronic remodelling. We have shown before that this remodelling conducts to accumulation of arterial tissue of lesser intrinsic stiffness. The latter finding was done through models based on echotracking measurements. It will be interesting to see whether it holds true when stiffness is directly measured.
Sixty subjects (30 normotensive and30 hypertensives) will be included and studied once. Measurement will be performed in random order 3 time on the common carotid artery on both sides. Aortic stiffness will be measured by pulse wave velocity
- Keywords
- Large arteries, stiffness, intima media thickness, ultrasound imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension patients | Local common carotid artery pulse wave velocity is compared in patients with hypertension and healthy volunteers. | |
| Healthy Volunteers | Local common carotid artery pulse wave velocity is compared in hypertension patients and healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local common carotid artery pulse wave velocity
Measured: Day 1
Secondary outcomes (1)
Common carotid artery Young's modulus (Stiffness of wall material)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Untreated 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Laurent, MD, PhD, Principal investigator, Pharmacology Department - Hopital Européen Georges Pompidou - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743352
- Sponsor's protocol ID
- 2012-01
- Other IDs
- ID - RCB 2012-A01255-38
- Status last verified
- Oct 2015
- First submitted
- 4 Dec 2012
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocole ULTRAFAST - ECHOTRACKING : Remodelage pariétal et rigidité artérielle Chez l'Hypertendu : Nouvelle étude de Leur Relation Utilisant l'élastographie Par Ultrafast-écho et la séparation Intima/média Par écho-tracking
- ClinicalTrials.gov ID
- NCT01743352
- Acronym / sponsor ID
- 2012-01
- Keywords
- Large arteries, stiffness, intima media thickness, ultrasound imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Dec 2012 (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 aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in hypertensive arteries.
Detailed description
Ultrafast ECHO is a new non invasive method for assessing stiffness of living tissues. It takes advantage of very fast imaging technologies (up to 20 000 images/sec) to measure the diffusion of pressure waves in the tissues. This pressure wave can be either natural (blood pressure), or generated by an very short ultrasonic impulsion at a given place. By using both modes, it is possible to have a precise cartography of tissue mechanical properties. This technique is applied to solid tissues such as breast or liver, but not yet currently to hollow tissues such as arteries. The aim of the present study is to compare the values of stiffness obtained with Ultrafast ECHO with the reference non invasive technique, the Echotracking, which measures stiffness by assessing the deformation of arteries in response to changes in blood pressure. On the physiological part, we will revisit old concepts of increased stiffness of hypertensive's arteries. Indeed, hypertension is associated with increased stiffness due to recruitement of collagen fibers, but also to chronic remodelling. We have shown before that this remodelling conducts to accumulation of arterial tissue of lesser intrinsic stiffness. The latter finding was done through models based on echotracking measurements. It will be interesting to see whether it holds true when stiffness is directly measured.
Sixty subjects (30 normotensive and30 hypertensives) will be included and studied once. Measurement will be performed in random order 3 time on the common carotid artery on both sides. Aortic stiffness will be measured by pulse wave velocity
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension patients | – | –Local common carotid artery pulse wave velocity is compared in patients with hypertension and healthy volunteers. |
| Healthy Volunteers | – | –Local common carotid artery pulse wave velocity is compared in hypertension patients and healthy volunteers |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting Essential untreated hypertension Healthy Volunteers
Key inclusion criteria (3 listed)
- hypertension,
- essential (WHO workup),
- untreated (> 28 days of treatment interruption, < 6 months of treatment) on insufficiently equilibrated (BP > 140 and/or 90 mmHg)
Key exclusion criteria (1 listed)
- Any concomitant severe disease compromising patient's participation or compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local common carotid artery pulse wave velocity
Time frame: Day 1
1 secondary outcome
Common carotid artery Young's modulus (Stiffness of wall material)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Related trials for Essential Untreated Hypertension
RecruitingObservational study
Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Adults With Newly Diagnosed Hypertension
Hypertension, Endothelial Function
RecruitingObservational study
Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension
Pediatric Hypertension, Primary Hypertension
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.
Stéphane Laurent, MD, PhD principal investigator
Pharmacology Department - Hopital Européen Georges Pompidou - Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Untreated Hypertension and Healthy Volunteers, run by French Cardiology Society 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local common carotid artery pulse wave velocity (time frame: Day 1). 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 2 Oct 2015.