Pathophysiological Mechanisms of Fibromuscular Dysplasia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01935752

Acronym

MeDyA

Enrollment

150

Registered

2013-09-05

Start date

2011-11-30

Completion date

2014-10-31

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromuscular Dysplasia

Keywords

fibromuscular, dysplasia, endothelium, microparticles, microRNA

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.

Interventions

OTHERblood samples

blood samples

OTHERvascular echotracking

endothelial function study and virtual histology study

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients	Once within 15 days

Secondary

Measure	Time frame
Comparison of matrixmetalloproteases between the 3 arms	Once within 15 days
Comparison of c-reactive protein between the 3 arms	Once within 15 days
Comparison of PLA2 between the 3 arms	Once within 15 days
Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms	Once within 15 days
Comparison of endothelium independent vasodilation between the 3 arms	Once within 15 days
Comparison of pulse wave velocity between the 3 arms	Once within 15 days
Comparison of endothelium dependant vasodilation between the 3 arms	Once within 15 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026