Fibromuscular DysplasiaMeDyANCT01935752
Pathophysiological Mechanisms of Fibromuscular Dysplasia
A study testing blood samples and vascular echotracking in people with Fibromuscular Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromuscular Dysplasia
- What is being tested?
- blood samples and vascular echotracking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Oct 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria for patients with multifocal fibromuscular dysplasia:
- confirmed multifocal fibromuscular dysplasia
- diagnosed for less than 10 years
- without significant atherosclerotic disease or recent cardiovascular event
- Statins and antiplatelet drugs are forbidden
- hypertensive patients
Trial locations and contacts
1 site in 1 country.
About this study
Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery, arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order to progress into identifying possible causative mechanisms of the disease, we design a pathophysiology study destined to assess endothelial function in patients with fibromuscular dysplasia and to identify possible plasmatic biomarkers of the disease.
- Conditions
- Fibromuscular Dysplasia
- Being tested
- blood samples, vascular echotracking
- Keywords
- fibromuscular, dysplasia, endothelium, microparticles, microRNA
- Medical subject headings
- Fibromuscular Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
blood samples
vascular echotrackingOther
endothelial function study and virtual histology study
| Study group | Role | What they receive |
|---|---|---|
| Fibromuscular dysplasia | Other | Fibromuscular dysplasia:blood samples \& vascular echotracking Receives: Other: blood samples; Other: vascular echotracking |
| healthy volunteer | Other | healthy volunteer:blood samples \& vascular echotracking Receives: Other: blood samples; Other: vascular echotracking |
| hypertensive patients | Other | hypertensive patients:blood samples \& vascular echotracking Receives: Other: blood samples; Other: vascular echotracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients
Measured: Once within 15 days
Secondary outcomes (7)
Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms
Measured: Once within 15 days
Comparison of matrixmetalloproteases between the 3 arms
Measured: Once within 15 days
Comparison of c-reactive protein between the 3 arms
Measured: Once within 15 days
Comparison of PLA2 between the 3 arms
Measured: Once within 15 days
Comparison of endothelium dependant vasodilation between the 3 arms
Measured: Once within 15 days
Comparison of endothelium independent vasodilation between the 3 arms
Measured: Once within 15 days
Comparison of pulse wave velocity between the 3 arms
Measured: Once within 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromuscular DysplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Responsible party
- Sponsor
- Investigators
- Michel Azizi, MD, PhD., Principal investigator, HEGP, APHP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935752
- Sponsor's protocol ID
- P110301
- Acronym
- MeDyA
- Status last verified
- Oct 2016
- First submitted
- 2 Sep 2013
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruno RM, Marais L, Khettab H, Lorthioir A, Frank M, Jeunemaitre X, Laurent S, Boutouyrie P, Azizi M. Deep Vascular Phenotyping in Patients With Renal Multifocal Fibromuscular Dysplasia. Hypertension. 2019 Feb;73(2):371-378. doi: 10.1161/HYPERTENSIONAHA.118.12189.
PubMed 30624987
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Mechanisms of Fibromuscular Dysplasia
- ClinicalTrials.gov ID
- NCT01935752
- Acronym / sponsor ID
- MeDyA / P110301
- Conditions
- Fibromuscular Dysplasia
- Keywords
- fibromuscular, dysplasia, endothelium, microparticles, microRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Study start
- Nov 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Sep 2013 (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.
Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery, arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order to progress into identifying possible causative mechanisms of the disease, we design a pathophysiology study destined to assess endothelial function in patients with fibromuscular dysplasia and to identify possible plasmatic biomarkers of the disease.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibromuscular dysplasia | Other | Other: blood samples, Other: vascular echotrackingFibromuscular dysplasia:blood samples \& vascular echotracking |
| healthy volunteer | Other | Other: blood samples, Other: vascular echotrackinghealthy volunteer:blood samples \& vascular echotracking |
| hypertensive patients | Other | Other: blood samples, Other: vascular echotrackinghypertensive patients:blood samples \& vascular echotracking |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| blood samplesblood samples | Other | Fibromuscular dysplasia, healthy volunteer, hypertensive patients |
| vascular echotrackingendothelial function study and virtual histology study | Other | Fibromuscular dysplasia, healthy volunteer, hypertensive patients |
Primary outcome
Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients
Time frame: Once within 15 days
7 secondary outcomes
Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms
Time frame: Once within 15 days
Comparison of matrixmetalloproteases between the 3 arms
Time frame: Once within 15 days
Comparison of c-reactive protein between the 3 arms
Time frame: Once within 15 days
Comparison of PLA2 between the 3 arms
Time frame: Once within 15 days
Comparison of endothelium dependant vasodilation between the 3 arms
Time frame: Once within 15 days
Comparison of endothelium independent vasodilation between the 3 arms
Time frame: Once within 15 days
Comparison of pulse wave velocity between the 3 arms
Time frame: Once within 15 days
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 18 Oct 2016.
- Derived from this study: PubMed 30624987Bruno RM, Marais L, Khettab H, Lorthioir A, Frank M, Jeunemaitre X, Laurent S, Boutouyrie P, Azizi M. Deep Vascular Phenotyping in Patients With Renal Multifocal Fibromuscular Dysplasia. Hypertension. 2019 Feb;73(2):371-378. doi: 10.1161/HYPERTENSIONAHA.118.12189.
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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.
Michel Azizi, MD, PhD. principal investigator
HEGP, APHP, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples and vascular echotracking in people with Fibromuscular Dysplasia, run by Assistance Publique - Hôpitaux de Paris 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?
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 18 Oct 2016. 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?
Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients (time frame: Once within 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01935752, which also lists 1 linked publication.
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 18 Oct 2016.