Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization

Bundle-Branch Block Clinical Trial

Official title:

Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00173342
• Other study ID #: 9461700620
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: June 2005

Study information

• Verified date: June 2005
• Source: National Taiwan University Hospital
• Contact: Mei-Hwan Wu, MD, PhD
• Phone: 886-2-23123456
• Email: mhwu[@]ha.mc.ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

This study is to determine 1) the incidence of altered right bundle conduction, including CRBBB, IRBBB or rsR’ pattern in the Taipei city based on the school survey databank from 1999 to 2002, 2) the associated cardiac lesions, 3) clinical presentations relevant to the altered right bundle conduction, 4) the association with QTc prolongation and dispersion and HRV from a 5-minutes recording. Finally, molecular characterization for those with CRBBB or Brugada pattern EKG, especially those with positive family history will be studied.

Description:

The EKG pattern and medical records from the school survey from 1999 to 2002 in Taipei city will be reviewed, and the basic data of those with CRBBB, IRBBB and rsR’ pattern will be recorded. Interview will be made and the echocardiographic measurements will be performed to identify associated cardiac defects. EKG parameters and QT, QTc, QT dispersion, QTc dispersion and HRV parameters will be obtained from a semi-automated system. Time domain and frequency domain measures will be calculated and expressed as SDNN, triangular index, SDNN index, total power, low frequency power and high frequency power. Mutational analysis and DNA sequencing will be conducted in those with CRBBB or Brugada pattern EKG, especially those with positive family history.

Based on these data, the clinical significance of altered bundle branch conduction identified from a school survey may be defined. For those with isolated CRBBB or IRBBB, the adjunctive value of HRV and QT parameters will determined the high risk group, and 24 hour Holter recording and Treadmill exercise test will then perform in these patients to define association with ventricular arrhythmia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 25 Years

Eligibility

Inclusion Criteria:

• ECG showed right bundle branch block

Exclusion Criteria:

• can't tolerate Treadmill ECG study

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Block

Locations

Country	Name	City	State
Taiwan	Department of Pediatrics, National Taiwan University Hospital	Taipei
Taiwan	Pediatric Department, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,