Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

Long QT Syndrome Clinical Trial

Official title:

Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705925
• Other study ID #: PDX-002-11
• Status: Completed
• Start date: March 2012
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• Children and/or young adults diagnosed with heterogeneous repolarization disorder who have genotype positive Long QT, or

• Newly diagnosed mutation positive patients with a confirmed test

Exclusion Criteria:

• Children who are phenotypically positive with no molecular testing

• Children that are phenotypically positive but genotype negative

Related Conditions & MeSH terms

• Long QT Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Children's Cardiology Associates	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.		Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
Secondary	Adverse Cardiac Events on patients with both phenotype and genotype positive.		Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.