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Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (DVDA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00999947
First received: September 29, 2009
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Cardiomyopathy
Arrhythmogenic Right Ventricular Dysplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Study of Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Determine the genetic origin in patients with ARVD/C whatever the familial context [ Time Frame: at inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood sample


Estimated Enrollment: 400
Study Start Date: September 2006
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Impossible to understand the notice information about study
  • Not affiliated with social protection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999947

Locations
France
Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Charron, MD, PhD Pitié Salpêtrière Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00999947     History of Changes
Other Study ID Numbers: P051067
Study First Received: September 29, 2009
Last Updated: October 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
genetics
mutation screening
phenotype-genotype analysis
desmosomal genes

Additional relevant MeSH terms:
Hyperplasia
Arrhythmogenic Right Ventricular Dysplasia
Cardiomyopathies
Pathologic Processes
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 22, 2013