The Canadian National Long QT Syndrome Registry

NCT02425189 | Completed

• 1 other identifier: H14-02344
• Study Type: observational
• Target: 1,051
• Locations: 1 country
• Sites: 1

Brief Summary

The NLQTS Research Network team aims to build a Canadian collaboration of dedicated investigators that will create a new paradigm in the modern investigation of patients with LQTS and in the description of a new disease modifier. The project aims to describe the natural history of familial Long QT Syndrome to identify:

1. 1.Low risk patients that do not require protective beta-blocker therapy
2. 2.High-risk patients that require protective beta-blocker therapy and may benefit from a primary prevention ICD. This cohort would contain treated pre-symptomatic individuals effectively protected from harm.

Conditions

Long QT Syndrome

Outcome Measures

Primary Outcomes (1)

• Natural Course of Long QT

  Changes to diagnosis, medications, treatments.

  Three Years

Study Arms (2)

LQT Positive (Group 1)

* Gene-positive LQTS patients * Gene negative LQTS patients with confirmed phenotypic diagnosis of LQTS (Schwartz score ≥4)

Asyptomatic Patients (Group 2)

Asymptomatic patients, those free of syncope on beta blocker, or gene negative unaffected family members

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with positive LQTS diagnosis and their family members reviewed in collaborating Canadian Inherited Arrhythmia Clinics will be invited to participate in the registry. Optional bio bank donation will be offered. Consenting participants will have blood work drawn in their local outpatient laboratory.

You may qualify if:

• All age groups will be included
• Gene-positive LQTS patients
• Gene negative LQTS patients with confirmed phenotypic diagnosis of LQTS (Schwartz score ≥4)
• Genotype- or phenotype- negative family members of gene- or phenotype- positive LQTS patients evaluated as part of family screening (cascade screening)
• Informed and willing consent

You may not qualify if:

• \. Geneotype- and phenotype-negative patients without an affected family member 2 .Unwilling or unable to provide informed consent

Sponsors & Collaborators

• Andrew Krahn: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6E 4V7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples drawn: 1 X 9 ml EDTA Samples for bio banking will be stored long-term

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

• Andrew D Krahn, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Head UBC Division of Cardiology

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: April 23, 2015
• Study Start: November 1, 2014
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

CA (1)