Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

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ClinicalTrials.gov Identifier: NCT00221832

Recruitment Status : Unknown

Verified October 2003 by Heidelberg University.
Recruitment status was: Recruiting

First Posted : September 22, 2005

Last Update Posted : January 13, 2010

Sponsor:

Information provided by:

Heidelberg University

Study Description

Brief Summary:

The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.

Condition or disease
Long QT Syndrome Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Dysplasia

Detailed Description:

Molecular genetic screening in patients with:

supraventricular
ventricular arrhythmia
syncopes of unknown origin and/or suspicion of an arrhythmogenic origin
family members of patients with sudden cardiac death and aborted sudden cardiac death

Examination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.

Study Design


Study Type :	Observational
Estimated Enrollment :	300 participants
Observational Model:	Family-Based
Time Perspective:	Prospective
Official Title:	Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
Study Start Date :	October 2003
Estimated Study Completion Date :	December 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Andersen-Tawil syndrome Jervell and Lange-Nielsen syndrome Romano-Ward syndrome Arrhythmogenic right ventricular cardiomyopathy Familial hypertrophic cardiomyopathy

Genetic and Rare Diseases Information Center resources: Brugada Syndrome Arrhythmogenic Right Ventricular Dysplasia Aortic Valve Stenosis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention: Samples With DNA

no biospecimens are to be retained.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Consecutive patient sampling with history of syncope, aborted SCD, familial sudden cardiac death, high suspicion of familial cardiac arrhythmias.

Criteria

Inclusion Criteria:

Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease
Patients with long QT syndrome
Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals
Patients with Brugada syndrome
Patients with hypertrophic cardiomyopathy
Patients with arrhythmogenic right ventricular dysplasia

Exclusion Criteria:

Inability to understand study protocol

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221832

Contacts


Contact: Christian Wolpert, MD	+49-621-383-2206	christian.wolpert@med.ma.uni-heidelberg.de
Contact: Rainer Schimpf, MD	+49-621-383-2206	rainer.schimpf@med.ma.uni-heidelberg.de

Locations


Germany
University Hospital Mannheim, I. Department of Medicine	Recruiting
Mannheim, Germany, 68167
Contact: Christian Wolpert, MD +49-621-3832206 christian.wolpert@med.ma.uni-heidelberg.de
Contact: Rainer Schimpf, MD +49-621-3832206 rainer.schimpf@med.ma.uni-heidelberg.de
Principal Investigator: Christian Wolpert, MD

Sponsors and Collaborators

Heidelberg University

Investigators


Study Director:	Martin Borggrefe, Prof., MD	I. Department of Medicine-Cardiology

More Information


Responsible Party:	Prof. C. Wolpert, I. Department of Medicine-Cardiology, University Hospital Mannheim, . Department of Medicine-Cardiology, University Hospital Mannheim
ClinicalTrials.gov Identifier:	NCT00221832 History of Changes
Other Study ID Numbers:	0261.5
First Posted:	September 22, 2005 Key Record Dates
Last Update Posted:	January 13, 2010
Last Verified:	October 2003

Keywords provided by Heidelberg University:


Long QT Syndrome Hypertrophic cardiomyopathy arrhythmogenic right ventricular dysplasia Short QT Syndrome Brugada Syndrome

Additional relevant MeSH terms:


Long QT Syndrome Syndrome Cardiomyopathies Hypertrophy Cardiomyopathy, Hypertrophic Arrhythmogenic Right Ventricular Dysplasia Disease Pathologic Processes Heart Diseases	Cardiovascular Diseases Pathological Conditions, Anatomical Aortic Stenosis, Subvalvular Aortic Valve Stenosis Heart Valve Diseases Arrhythmias, Cardiac Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities

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