Pathophysiological Mechanisms of Fibromuscular Dysplasia

Fibromuscular Dysplasia Clinical Trial

— MeDyA  

Official title:

Pathophysiological Mechanisms of Fibromuscular Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935752
• Other study ID #: P110301
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: October 17, 2016
• Start date: November 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fibromuscular Dysplasia
• Hyperplasia

Intervention

Other:
• blood samples
blood samples
• vascular echotracking
endothelial function study and virtual histology study

Locations

Country	Name	City	State
France	Cic9201, Hegp, Aphp,	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation pour la Recherche Médicale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients		Once within 15 days	No
Secondary	Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms		Once within 15 days	No
Secondary	Comparison of matrixmetalloproteases between the 3 arms		Once within 15 days	No
Secondary	Comparison of c-reactive protein between the 3 arms		Once within 15 days	No
Secondary	Comparison of PLA2 between the 3 arms		Once within 15 days	No
Secondary	Comparison of endothelium dependant vasodilation between the 3 arms		Once within 15 days	No
Secondary	Comparison of endothelium independent vasodilation between the 3 arms		Once within 15 days	No
Secondary	Comparison of pulse wave velocity between the 3 arms		Once within 15 days	No