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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Mednax Center for Research, Education and Quality
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier:
NCT01705925
First received: October 4, 2012
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
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.

Condition
Long QT Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

Resource links provided by NLM:


Further study details as provided by Mednax Center for Research, Education and Quality:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and Young Adults with Genotype Positive Long QT Syndrome
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705925

Contacts
Contact: Amy Kelleher, MSHS amy_kelleher@pediatrix.com

Locations
United States, Arizona
Arizona Pediatric Cardiology Consultants Recruiting
Phoenix, Arizona, United States, 85006
Contact: Mitchell Cohen, MD    602-253-6000    mitchell_cohen@pediatrix.com   
Principal Investigator: Mitchell Cohen, MD         
United States, Texas
Children's Cardiology Associates Recruiting
Austin, Texas, United States, 78756
Contact: Arnold Fenrich, MD    512-480-0143    arnold_fenrich@pediatrix.com   
Principal Investigator: Arnold Fenrich, MD         
Sponsors and Collaborators
Mednax Center for Research, Education and Quality
Investigators
Principal Investigator: Mitchell Cohen, M.D. Mednax Center for Research, Education and Quality
Principal Investigator: Alan Spitzer, MD Mednax Center for Research, Education and Quality
  More Information

Responsible Party: Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier: NCT01705925     History of Changes
Other Study ID Numbers: PDX-002-11 
Study First Received: October 4, 2012
Last Updated: March 22, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Long QT Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 25, 2016