Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia (PROFILE)
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|ClinicalTrials.gov Identifier: NCT02961868|
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromuscular Dysplasia||Other: Abdominal and supra-aortic trunks vascular imaging Genetic: Blood sampling (genetic) Other: Blood sampling (biomarkers) Other: Urine sampling||Not Applicable|
Fibromuscular dysplasia (FMD) is a group of nonatherosclerotic, noninflammatory arterial diseases that usually involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. The prevalence of FMD in hypertensive patients is estimated at 4/1000. Angiographic classification includes the multifocal type, with multiple stenoses and the 'string-of-beads' appearance that is related to medial FMD, and tubular and focal types which are not clearly related to specific histological lesions. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD appears to be familial in 10% of cases (OMIM #135580).
Renal artery FMD may progress to more severe stenosis and to renal atrophy, and/or to stenoses affecting more arteries within or outside the renal vasculature. The risk of progression as assessed from available studies was probably overestimated because documentation of progression was obtained from angiography, a procedure which is not routinely undertaken in patients with favourable clinical and biological outcomes. The disease is progressive, however, and literature stated that patients with FMD should undergo yearly duplex ultrasonography to detect progression of disease, restenosis, or loss of kidney volume.
There are very few data on prognosis of patients with symptomatic carotid or vertebral artery FMD. The risk of arterial disease progression over time is unknown. The risk of ischemic stroke ranged from 0 to about 3% per year in the few studies which assessed that issue.
The primary objective is to estimate the incidence and risk factors for progression of FMD lesions. This will be assessed by comparison between initial and 3 years abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or Magnetic Resonance (MR) angiography), monitoring of downstream consequences development of lesions progression and clinical events.
The secondary objectives are:
- to estimate rate of genetic polymorphism that may influence disease progression or be associated with complications
- to assess the frequency of multi-site FMD (common objective with the ARCADIA study)
- to collect standardized clinical, radiological, and biological data in patients with FMD through a national registry (common objective with the ARCADIA study)
- to organize a clinical, radiological and biological database and a biobank that will constitute a unique resource to initiate further clinical research (common objective with the ARCADIA study).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROgression of FIbromuscular LEsions|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Experimental: Prospective cohort
3 years follow-up
Other: Abdominal and supra-aortic trunks vascular imaging
Abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression.
Genetic: Blood sampling (genetic)
A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications.
Other: Blood sampling (biomarkers)
A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
Other: Urine sampling
A sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
- Progression of fibromuscular dysplasia lesions confirmed by imaging [ Time Frame: 3 years ]
- Glomerular filtration rate (GFR) [ Time Frame: Inclusion, 3 years ]
- Kidney height [ Time Frame: Inclusion, 3 years ]
- Clinical event: revascularization procedure in a lesion site [ Time Frame: Through study completion ]
- Clinical event: renal infarction [ Time Frame: Through study completion ]
- Clinical event: ischemic stroke [ Time Frame: Through study completion ]
- Clinical event: arterial dissection in a lesion site or downstream from a lesion site [ Time Frame: Through study completion ]
- Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site [ Time Frame: Through study completion ]
- Prevalence of multisite fibromuscular dysplasia confirmed by imaging [ Time Frame: Inclusion, 3 years ]
- Single nucleotide polymorphisms [ Time Frame: Inclusion ]Assessed by genome-wide association
- Plasminogen/plasmin level [ Time Frame: Inclusion ]
- Matrix metalloproteinases level [ Time Frame: Inclusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961868
|Principal Investigator:||Pierre-François Plouin, MD||Assistance Publique - Hôpitaux de Paris|