Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy - Full Text View

Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (DVDA)

This study is currently recruiting participants.

Verified October 2009 by Assistance Publique - Hôpitaux de Paris

First Received on September 29, 2009. Last Updated on October 21, 2009 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00999947

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:

Genetics Home Reference related topics: arrhythmogenic right ventricular cardiomyopathy Help Me Understand Genetics

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:	September 2012
Estimated Primary Completion Date:	September 2012 (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

Contacts

Contact: Philippe Charron, MD, PhD

+ 33 (1) 42 16 13 47 ext 28 98

philippe.charron@psl.aphp.fr

Locations

France
Pitié-Salpêtrière Hospital	Recruiting
Paris, France, 75013
Principal Investigator: Philippe Charron, MD, PhD

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:	Saliha DJANE, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00999947 History of Changes
Other Study ID Numbers:	P051067
Study First Received:	September 29, 2009
Last Updated:	October 21, 2009
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 February 09, 2012