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

Tracking Information

First Submitted Date

September 14, 2005

First Posted Date

September 22, 2005

Last Update Posted Date

January 13, 2010

Study Start Date

October 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Official Title

Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Brief Summary

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

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 Type

Observational

Study Design

Observational Model: Family-Based
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

no biospecimens are to be retained.

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.

Condition

Long QT Syndrome
Hypertrophic Cardiomyopathy
Arrhythmogenic Right Ventricular Dysplasia

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Unknown status

Estimated Enrollment

300

Original Enrollment

Not Provided

Estimated Study Completion Date

December 2011

Primary Completion Date

Not Provided

Eligibility 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Older Adult

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Germany

Removed Location Countries

Administrative Information

NCT Number

NCT00221832

Other Study ID Numbers

0261.5

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Prof. C. Wolpert, I. Department of Medicine-Cardiology, University Hospital Mannheim, . Department of Medicine-Cardiology, University Hospital Mannheim

Study Sponsor

Heidelberg University

Collaborators

Not Provided

Investigators

Study Director:

Martin Borggrefe, Prof., MD

I. Department of Medicine-Cardiology

PRS Account

Heidelberg University

Verification Date

October 2003

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