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Pulmonary Involvement in Patients With Fabry Disease

This study is not yet open for participant recruitment.
Verified June 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01632111
First received: June 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

The objective of this study is to investigate whether Agalsidase alpha, a drug commonly prescribed in patients with Fabry disease, is associated with improvement of the pulmonary involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the surrogate markers for obstructive lung diseases are a decrease in both forced expiratory volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity. However, the measurement of these lung function parameters is indicated as yearly follow-up examinations with or without the treatment of Agalsidase alpha in patients with Fabry disease.


Condition Intervention
Fabry Disease
 Other: Lung function measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of the Treatment With Agalsidase Alpha on Lung Function and on Pulmonary Involvement in Patients With Fabry Disease. A Multicenter, Retrospective Observational Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Lung function measurement
    Spirometry
    Other Name: FEV1, FVC
Detailed Description:

Pulmonary function tests und DLCO measurements are performed yearly in relation with yearly follow up examinations in the Department of Internal Medicine from the University Hospital of Zurich. We will retrospectively collect the results of the pulmonary functions test (spirometry).

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Ambulatory patients at University Hospital of Zurich with Fabry disease

Criteria

Inclusion criteria:

  • All patients with established diagnosis of Fabry disease

Exclusion criteria:

  • Missing informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632111

Contacts
Contact: Daniel Franzen, MD daniel.franzen@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine Not yet recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Division of Internal Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01632111     History of Changes
Other Study ID Numbers: Fabry
Study First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Fabry Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 16, 2013