Pathophysiological Mechanisms of Fibromuscular Dysplasia

Not Applicable

Completed

• Conditions: Fibromuscular Dysplasia
• Interventions: Other: blood samples; Other: vascular echotracking

• Registration Number: NCT01935752
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibromuscular dysplasia	blood samples	Fibromuscular dysplasia:blood samples \& vascular echotracking
hypertensive patients	vascular echotracking	hypertensive patients:blood samples \& vascular echotracking
healthy volunteer	blood samples	healthy volunteer:blood samples \& vascular echotracking
healthy volunteer	vascular echotracking	healthy volunteer:blood samples \& vascular echotracking
hypertensive patients	blood samples	hypertensive patients:blood samples \& vascular echotracking
Fibromuscular dysplasia	vascular echotracking	Fibromuscular dysplasia:blood samples \& vascular echotracking

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms	Once within 15 days
Comparison of c-reactive protein 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
Comparison of endothelium independent vasodilation between the 3 arms	Once within 15 days
Comparison of matrixmetalloproteases between the 3 arms	Once within 15 days
Comparison of PLA2 between the 3 arms	Once within 15 days

Trial Locations

Locations (1)

Cic9201, Hegp, Aphp,; 🇫🇷 Paris, France