Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (DVDA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00999947
First received: September 29, 2009
Last updated: November 21, 2013
Last verified: October 2012
  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:


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


Enrollment: 351
Study Start Date: September 2006
Study Completion Date: March 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hôpital de la Salpétrière
  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: November 21, 2013
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:
Cardiomyopathies
Arrhythmogenic Right Ventricular Dysplasia
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 30, 2014