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Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada (FHCanada)

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ClinicalTrials.gov Identifier: NCT02009345
Recruitment Status : Recruiting
First Posted : December 12, 2013
Last Update Posted : June 23, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients. The goal of this initiative is to create a registry of subjects with FH across Canada. Rare diseases of lipoprotein metabolism will also be included. Using a "hub and spoke" model, the registry will be extended in various communities to link primary care physicians with provincial academic centers. The registry will include clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) will be collected for biobanking. We propose a three-tier registry: local, provincial and Canada-wide, which will be completely anonymized. The registry will be made available for clinicians to manage patient care, identify relatives for screening and treatment (cascade screening), to provide advice to general practitioners and to support collaborative studies in biomedical, clinical, health outcomes and health economics research. The data extracted for the provincial portion of the database will allow administrative database research that will provide important information to key stakeholders and permit allocation of resources. It will also allow a sound and uniform rationale for the use of novel therapeutic agents and provide expert advice to regulatory agencies. At the Canadian level, the database will allow clinicians and researchers to determine the burden of disease and the long-term effects of treatment. Through the creation of a Canada-wide network of academic clinics, integrating lipid specialists, endocrinologists and cardiologists, the Canadian FH registry will lead to significant benefits for FH patients, clinicians and researchers, biopharmaceutical industry and government.

Condition or disease
Familial Hypercholesterolemia Lipid Disorder

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Target Follow-Up Duration: 15 Years
Official Title: Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Number of Patients with FH [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Prevalence rates of FH in Canada [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Plasma and Buffy coat for DNA extraction DNA stock samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from primary care clinics

Inclusion Criteria:

Diagnostic criteria for FH, which are:

  • Family and/or personal history of high cholesterol
  • Family and/or personal history of heart disease
  • Abnormal growth on tendons, accumulation of fatty material in the eye Family history of FH Severe disorder of cholesterol and other lipids in the blood

Exclusion Criteria:

No exclusion criterion

Contacts and Locations

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): NCT02009345

Contact: Isabelle Ruel, PhD 514-934-1934 ext 34852 isabelle.ruel@mail.mcgill.ca

Canada, Quebec
Research Institute of the McGill University Health Centre: Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Isabelle Ruel, PhD    514-934-1934 ext 34258    isabelle.ruel@mail.mcgill.ca   
Principal Investigator: Jacques Genest, MD         
Sponsors and Collaborators
McGill University Health Center
Merck Sharp & Dohme Corp.
Aegerion Pharmaceuticals, Inc.
Principal Investigator: Jacques Genest, MD Research Institute of the McGill University Health Centre
More Information

Responsible Party: Jacques Genest, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02009345     History of Changes
Other Study ID Numbers: FH Canada
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Jacques Genest, McGill University Health Center:
Familial hypercholesterolemia,
High LDL-cholesterol
Coronary artery disease

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn