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

NCT01705925 | Completed

• 1 other identifier: PDX-002-11
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• 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.

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and Young Adults with Genotype Positive Long QT Syndrome

You may qualify if:

• 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

You may not qualify if:

• Children who are phenotypically positive with no molecular testing
• Children that are phenotypically positive but genotype negative

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (1)

Children's Cardiology Associates

Austin, Texas, 78756, United States

Location

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchell Cohen, M.D.

  Pediatrix

  PRINCIPAL INVESTIGATOR

• Arnold Fenrich, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

• Reese Clark, MD

  Pediatrix

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 12, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)