RecruitingNCT00455104

Canadian Fabry Disease Initiative (CFDI) National Registry

Canadian Fabry Disease Initiative National Registry: Outcomes of Rare Disease Therapeutics and Cardiovascular Risk Factor Modification


Sponsor

Canadian Fabry Research Consortium

Enrollment

600 participants

Start Date

Jan 1, 2007

Study Type

OBSERVATIONAL

Conditions

Summary

CFDI NATIONAL REGISTRY Fabry disease is a rare, inherited, genetic condition due to a deficiency of an enzyme called alpha-galactosidase A. This enzyme deficiency causes the small blood vessels to accumulate a substance called glycolipid. Without sufficient levels of the enzyme, alpha-galactosidase A, persons with Fabry Disease develop severe neuropathic pain, kidney disease, heart disease, stroke and/or premature death; often before the age of 60. Fabry Disease is estimated to affect approximately one out of every 40,000 males and up to twice as many females in Canada. We do not have the exact number of persons in Canada who have this disease. A common problem in studying rare conditions is the difficulty in identifying the majority of people suffering from such a disease. Gathering their health information in order to better understand the natural disease progression and its response to treatment is difficult. Early ERT studies involving humans had small numbers of subjects and the studies were of short duration. The results of these clinical studies did lead to approval of the therapy in many countries around the world including Canada. To date though, evidence of the usefulness of ERT and its direct impact on the natural course of Fabry disease has been limited, while its cost continues to be very high. As a result of these issues, there will need to be continued and long-term collection of information related to the effectiveness of ERT and other treatments to better document its true clinical outcomes in Canadian people with Fabry disease. The Canadian Fabry Disease Initiative National Registry (CFDI-NR) is an observational, voluntary registry designed to collect outcomes data on Fabry disease from people living in Canada.


Eligibility

Min Age: 5 YearsMax Age: 85 Years

Inclusion Criteria5

  • Age 5 years and older, up to \& including age 85 years; and
  • Able to give informed consent; and
  • A clinical diagnosis of Fabry disease; and
  • Compliance with all the clinic visits, interviews and assessments during the study period; and
  • A Canadian citizen or a landed immigrant

Exclusion Criteria5

  • Inability to give informed consent; or
  • Problem complying with all the clinic visits, interviews and assessments during the study period; or
  • An estimated life expectancy of less than 12 months
  • Under 5 years of age
  • Non-disease causing mutation

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Interventions

OTHERNo intervention

This is an observational, voluntary registry.


Locations(5)

Alberta Children's Hospital

Calgary, Alberta, Canada

Vancouver General Hospital Adult Metabolic Diseases Clinic

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

University of Montreal, Department of Medicine

Montreal, Quebec, Canada

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NCT00455104


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