NCT00221832

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 13, 2010

Status Verified

October 1, 2003

First QC Date

September 14, 2005

Last Update Submit

January 12, 2010

Conditions

Long QT SyndromeHypertrophic CardiomyopathyArrhythmogenic Right Ventricular Dysplasia

Keywords

Long QT SyndromeHypertrophic cardiomyopathyarrhythmogenic right ventricular dysplasiaShort QT SyndromeBrugada Syndrome

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Inability to understand study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Mannheim, I. Department of Medicine

Mannheim, 68167, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

no biospecimens are to be retained.

MeSH Terms

Conditions

Long QT SyndromeCardiomyopathy, HypertrophicArrhythmogenic Right Ventricular DysplasiaShort Qt SyndromeBrugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesGenetic Diseases, Inborn

Study Officials

  • Martin Borggrefe, Prof., MD

    I. Department of Medicine-Cardiology

    STUDY DIRECTOR

Central Study Contacts

Christian Wolpert, MD

CONTACT

+49-621-383-2206christian.wolpert@med.ma.uni-heidelberg.de

Rainer Schimpf, MD

CONTACT

+49-621-383-2206rainer.schimpf@med.ma.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

October 1, 2003

Study Completion

December 1, 2011

Last Updated

January 13, 2010

Record last verified: 2003-10

Locations

DE(1)