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The Canadian National Long QT Syndrome Registry (LQTSREG)

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ClinicalTrials.gov Identifier: NCT02425189
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Krahn, University of British Columbia

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. Low risk patients that do not require protective beta-blocker therapy
  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.

Condition or disease
Long QT Syndrome

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: National Long QT Syndrome Registry: Canadian Genetic Heart Rhythm Network |Research Data Registry and Bio Bank
Study Start Date : November 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Natural Course of Long QT [ Time Frame: Three Years ]
    Changes to diagnosis, medications, treatments.


Biospecimen Retention:   Samples With DNA

Blood Samples drawn:

1 X 9 ml EDTA

Samples for bio banking will be stored long-term



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion:

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


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): NCT02425189


Contacts
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Contact: Karen A Gibbs 604-682-2344 ext 63260 kgibbs@providencehealth.bc.ca

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6E 4V7
Contact: Andrew D Krahn, MD    604-682-2344 ext 63260      
Contact: Karen Gibbs, RN    604-682-2344 ext 66860    kgibbs@providencehealth.bc.ca   
Sponsors and Collaborators
Andrew Krahn
Investigators
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Principal Investigator: Andrew D Krahn, MD University of British Columbia

Additional Information:

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Responsible Party: Andrew Krahn, Professor of Medicine and Head UBC Division of Cardiology, University of British Columbia
ClinicalTrials.gov Identifier: NCT02425189     History of Changes
Other Study ID Numbers: H14-02344
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 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