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Trial record 8 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

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

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ClinicalTrials.gov Identifier: NCT01705925
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Brief 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.

Condition or disease
Long QT Syndrome

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
Actual Study Start Date : March 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705925


Locations
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United States, Texas
Children's Cardiology Associates
Austin, Texas, United States, 78756
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
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Principal Investigator: Mitchell Cohen, M.D. Mednax Center for Research, Education, Quality and Safety
Principal Investigator: Arnold Fenrich, MD Mednax Center for Research, Education, Quality and Safety
Study Director: Reese Clark, MD Mednax Center for Research, Education, Quality and Safety

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Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT01705925     History of Changes
Other Study ID Numbers: PDX-002-11
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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