NCT00999947

Brief Summary

The purpose of this trial is to study the genetic and phenotypic aspects of Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C), and determine the impact of genetic testing in clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

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

September 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

October 1, 2012

Enrollment Period

6.5 years

First QC Date

September 29, 2009

Last Update Submit

November 21, 2013

Conditions

CardiomyopathyArrhythmogenic Right Ventricular Dysplasia

Keywords

geneticsmutation screeningphenotype-genotype analysisdesmosomal genes

Outcome Measures

Primary Outcomes (1)

  • Determine the genetic origin in patients with ARVD/C whatever the familial context

    at inclusion

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Unrelated patients with ARVD/C. A clinical diagnosis of ARVD/C is made according to the established European Society of Cardiology / International Society and Federation of Cardiology Task Force major and minor criteria (Task Force 1994) \+ All available relatives will be proposed for enrollement in the study

You may qualify if:

  • Patient with DVDA diagnostic confirmed
  • Acceptance even follow-up
  • Informed consent

You may not qualify if:

  • Impossible to understand the notice information about study
  • Not affiliated with social protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

CardiomyopathiesArrhythmogenic Right Ventricular Dysplasia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Philippe Charron, MD, PhD

    Pitié-Salpêtrière Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2009

First Posted

October 22, 2009

Study Start

September 1, 2006

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 25, 2013

Record last verified: 2012-10

Locations

FR(1)