Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Fibromuscular Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Prospective cohort

3 years follow-up

Group Type EXPERIMENTAL

Abdominal and supra-aortic trunks vascular imaging

Intervention Type OTHER

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.

Blood sampling (genetic)

Intervention Type 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.

Blood sampling (biomarkers)

Intervention Type OTHER

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.

Urine sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type GENETIC

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-François Plouin, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Site Status

CHU de Bordeaux hopital Saint-Andre

Bordeaux, Aquitaine-Limousin-Poitou-Charentes, France

Site Status

CHU de Clermont-Ferrand hopital Gabriel-Montpied

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Site Status

CHU de Grenoble hopital Albert-Michallon

La Tronche, Auvergne-Rhône-Alpes, France

Site Status

CHU de Nancy institut Louis-Mathieu

Vandeuvre-les-Nancy, Grand Est, France

Site Status

CHRU de Lille hopital cardiologique

Lille, Hauts-de-France, France

Site Status

CHRU de Lille hopital Roger-Salengro

Lille, Hauts-de-France, France

Site Status

CHU de Caen hopital Cote de Nacre

Caen, Normandy, France

Site Status

CHU de Toulouse hopital Rangueil

Toulouse, Occitanie, France

Site Status

AP-HM hopital de la Timone

Marseille, Provence-Alpes-Côte d'Azur Region, France

Site Status