Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

Sponsor:

Information provided by:

Heidelberg University

ClinicalTrials.gov Identifier:

NCT00221832

First received: September 14, 2005

Last updated: January 12, 2010

Last verified: October 2003

History of Changes

Purpose

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

Condition
Long QT Syndrome Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Dysplasia


Study Type:	Observational
Study Design:	Observational Model: Family-Based Time Perspective: Prospective
Official Title:	Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Resource links provided by NLM:

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

Further study details as provided by Heidelberg University:

Biospecimen Retention: Samples With DNA

no biospecimens are to be retained.


Estimated Enrollment:	300
Study Start Date:	October 2003
Estimated Study Completion Date:	December 2011

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.

Eligibility


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

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: 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
Study First Received:	September 14, 2005
Last Updated:	January 12, 2010

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

ClinicalTrials.gov processed this record on September 21, 2017

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