Clinical trial NCT01935752: Pathophysiological Mechanisms of Fibromuscular Dysplasia
Official title: Pathophysiological Mechanisms of Fibromuscular Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromuscular Dysplasia
Keywords: fibromuscular
dysplasia
endothelium
microparticles
microRNA
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation pour la Recherche Médicale
First posted: 2013-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients
timeFrame: Once within 15 days
Secondary outcomes:
measure: Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms
timeFrame: Once within 15 days
measure: Comparison of matrixmetalloproteases between the 3 arms
timeFrame: Once within 15 days
measure: Comparison of c-reactive protein between the 3 arms
timeFrame: Once within 15 days
measure: Comparison of PLA2 between the 3 arms
timeFrame: Once within 15 days
measure: Comparison of endothelium dependant vasodilation between the 3 arms
timeFrame: Once within 15 days
measure: Comparison of endothelium independent vasodilation between the 3 arms
timeFrame: Once within 15 days
measure: Comparison of pulse wave velocity between the 3 arms
timeFrame: Once within 15 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Cic9201, Hegp, Aphp,
Study officials:
affiliation: HEGP, APHP, Paris, France
name: Michel Azizi, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.