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

May 3, 2019 updated by: Pediatrix
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78756
        • Children's Cardiology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and Young Adults with Genotype Positive Long QT Syndrome

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Time Frame
Adverse Cardiac Events on patients with both phenotype and genotype positive.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Investigators

  • Principal Investigator: Mitchell Cohen, M.D., Pediatrix
  • Principal Investigator: Arnold Fenrich, MD, Pediatrix
  • Study Director: Reese Clark, MD, Pediatrix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (ESTIMATE)

October 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX-002-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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