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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
Sponsor:
Collaborator:
Fondation de Recherche sur l'Hypertension Artérielle
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.

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

Detailed Description:

Background

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.

Objectives

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PROgression of FIbromuscular LEsions
Actual Study Start Date : November 2009
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Progression of fibromuscular dysplasia lesions confirmed by imaging [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Glomerular filtration rate (GFR) [ Time Frame: Inclusion, 3 years ]
  2. Kidney height [ Time Frame: Inclusion, 3 years ]
  3. Clinical event: revascularization procedure in a lesion site [ Time Frame: Through study completion ]
  4. Clinical event: renal infarction [ Time Frame: Through study completion ]
  5. Clinical event: ischemic stroke [ Time Frame: Through study completion ]
  6. Clinical event: arterial dissection in a lesion site or downstream from a lesion site [ Time Frame: Through study completion ]
  7. Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site [ Time Frame: Through study completion ]
  8. Prevalence of multisite fibromuscular dysplasia confirmed by imaging [ Time Frame: Inclusion, 3 years ]
  9. Single nucleotide polymorphisms [ Time Frame: Inclusion ]
    Assessed by genome-wide association

  10. Plasminogen/plasmin level [ Time Frame: Inclusion ]
  11. Matrix metalloproteinases level [ Time Frame: Inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with renal or craniocervical fibromuscular dysplasia diagnosed during the 2 years before inclusion
  • The fibromuscular dysplasia is documented by imaging (angiography, CT-angiography, MR-angiography) of less than 2 years and validated by a radiologist investigator
  • Patient who understood and signed inform consent form
  • Affiliated to the French health insurance system
  • Available for a 3 years follow-up

Exclusion Criteria:

  • Patient with renal or craniocervical atherosclerosis, or inflammatory vascular disease as dominant pathological features
  • Patient with renal or craniocervical arteries dissection or aneurysm without any other evidence of fibromuscular dysplasia
  • Patient under 18 or under tutorship
  • Known pregnancy

Information from the National Library of Medicine

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


Locations
Show Show 17 study locations
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de Recherche sur l'Hypertension Artérielle
Investigators
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Principal Investigator: Pierre-François Plouin, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02961868    
Other Study ID Numbers: P071241
P071241 ( Other Identifier: Assistance Publique - Hopitaux de Paris )
2009-A00288-49 ( Other Identifier: Agence Française de Securite Sanitaire des Produits de Sante )
PHRC-08-192 ( Other Grant/Funding Number: Direction Generale de l'Offre de Soin )
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Renal Artery Obstruction
Carotid Artery Diseases
Genetic Association Studies
Additional relevant MeSH terms:
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Fibromuscular Dysplasia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases