Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00221832
• Other study ID #: 0261.5
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2005
• Last updated: January 12, 2010
• Start date: October 2003
• Est. completion date: December 2011

Study information

• Verified date: October 2003
• Source: Heidelberg University
• Contact: Christian Wolpert, MD
• Phone: +49-621-383-2206
• Email: christian.wolpert[@]med.ma.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Long QT Syndrome

Locations

Country	Name	City	State
Germany	University Hospital Mannheim, I. Department of Medicine	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany,