Pulmonary Involvement in Patients With Fabry Disease

NCT ID: NCT01632111

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Fabry Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Lung function measurement

Spirometry

Intervention Type OTHER

Other Intervention Names

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FEV1, FVC

Eligibility Criteria

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Inclusion Criteria

* All patients with established diagnosis of Fabry disease

Exclusion Criteria

* Missing informed consent
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Internal Medicine

Locations

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University Hospital Zurich, Division of Internal Medicine

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Fabry

Identifier Type: -

Identifier Source: org_study_id

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