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

Fibromuscular Dysplasia Clinical Trial

— PROFILE  

Official title:

PROgression of FIbromuscular LEsions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961868
• Other study ID #: P071241
• Secondary ID: P0712412009-A002
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: January 2018

Study information

• Verified date: September 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromuscular Dysplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Brussels-Capital Region
France	CHU de Bordeaux hopital Saint-Andre	Bordeaux	Aquitaine-Limousin-Poitou-Charentes
France	CHU de Caen hopital Cote de Nacre	Caen	Normandie
France	CHU de Clermont-Ferrand hopital Gabriel-Montpied	Clermont-Ferrand	Auvergne-Rhone-Alpes
France	CHU de Grenoble hopital Albert-Michallon	La Tronche	Auvergne-Rhone-Alpes
France	Centre Hospitalier de Versailles hopital Andre Mignot	Le Chesnay	Ile-de-France
France	CHRU de Lille hopital cardiologique	Lille	Hauts-de-France
France	CHRU de Lille hopital Roger-Salengro	Lille	Hauts-de-France
France	AP-HM hopital de la Timone	Marseille	Provence-Alpes-Cote d'Azur
France	AP-HP hopital Bichat-Claude-Bernard	Paris	Ile-de-France
France	AP-HP hopital Lariboisiere	Paris	Ile-de-France
France	AP-HP hopital Pitie-Salpetriere	Paris	Ile-de-France
France	AP-HP hopital Tenon	Paris	Ile-de-France
France	Centre hospitalier Sainte-Anne	Paris	Ile-de-France
France	Groupe Hospitalier Paris Saint-Joseph	Paris	Ile-de-France
France	CHU de Toulouse hopital Rangueil	Toulouse	Languedoc-Roussillon-Midi-Pyrenees
France	CHU de Nancy institut Louis-Mathieu	Vandeuvre-les-Nancy	Alsace-Champagne-Ardenne-Lorraine

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de Recherche sur l'Hypertension Artérielle

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of fibromuscular dysplasia lesions confirmed by imaging		3 years
Secondary	Glomerular filtration rate (GFR)		Inclusion, 3 years
Secondary	Kidney height		Inclusion, 3 years
Secondary	Clinical event: revascularization procedure in a lesion site		Through study completion
Secondary	Clinical event: renal infarction		Through study completion
Secondary	Clinical event: ischemic stroke		Through study completion
Secondary	Clinical event: arterial dissection in a lesion site or downstream from a lesion site		Through study completion
Secondary	Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site		Through study completion
Secondary	Prevalence of multisite fibromuscular dysplasia confirmed by imaging		Inclusion, 3 years
Secondary	Single nucleotide polymorphisms	Assessed by genome-wide association	Inclusion
Secondary	Plasminogen/plasmin level		Inclusion
Secondary	Matrix metalloproteinases level		Inclusion