NCT01935752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

September 2, 2013

Last Update Submit

October 17, 2016

Conditions

Fibromuscular Dysplasia

Keywords

fibromusculardysplasiaendotheliummicroparticlesmicroRNA

Outcome Measures

Primary Outcomes (1)

  • Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients

    Once within 15 days

Secondary Outcomes (7)

  • Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms

    Once within 15 days

  • 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 endothelium dependant vasodilation between the 3 arms

    Once within 15 days

  • +2 more secondary outcomes

Study Arms (3)

Fibromuscular dysplasia

OTHER

Fibromuscular dysplasia:blood samples \& vascular echotracking

Other: blood samplesOther: vascular echotracking

healthy volunteer

OTHER

healthy volunteer:blood samples \& vascular echotracking

Other: blood samplesOther: vascular echotracking

hypertensive patients

OTHER

hypertensive patients:blood samples \& vascular echotracking

Other: blood samplesOther: vascular echotracking

Interventions

blood samplesOTHER

blood samples

Fibromuscular dysplasiahealthy volunteerhypertensive patients
vascular echotrackingOTHER

endothelial function study and virtual histology study

Fibromuscular dysplasiahealthy volunteerhypertensive patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cic9201, Hegp, Aphp,

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 30624987DERIVED

MeSH Terms

Conditions

Fibromuscular Dysplasia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Michel Azizi, MD, PhD.

    HEGP, APHP, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 5, 2013

Study Start

November 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

FR(1)