NCT00871611

Brief Summary

The prevalence of Anderson - Fabry disease in patients with left ventricular hypertrophy is unclear. The investigators will examine urine - α - Galactosidase activity and globotriaosylceramide isoforms in these patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

3 years

First QC Date

March 27, 2009

Last Update Submit

July 27, 2011

Conditions

Fabry DiseaseLeft Ventricular Hypertrophy

Keywords

HereditaryAnderson-Fabryprevalencehearthypertrophyurineglobotriaosylceramideisoformsα - Galactosidase

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Anderson - Fabry disease

    2 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with left ventricular hypertrophy diagnosed by echocardiography

You may qualify if:

  • Patients with myocardial septum wall thickness ≥ 12mm

You may not qualify if:

  • Patients \< 18 years
  • Patients unable to provide urine sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine II, Div. Cardiology, Vienna General Hospital

Vienna, 1090, Austria

Location

Related Publications (4)

  • Weidemann F, Breunig F. [Cardiac involvement in Fabry's disease]. Med Klin (Munich). 2008 Mar 15;103(3):161-5. doi: 10.1007/s00063-008-1023-1. German.

    PMID: 18344066BACKGROUND

  • Linhart A, Kampmann C, Zamorano JL, Sunder-Plassmann G, Beck M, Mehta A, Elliott PM; European FOS Investigators. Cardiac manifestations of Anderson-Fabry disease: results from the international Fabry outcome survey. Eur Heart J. 2007 May;28(10):1228-35. doi: 10.1093/eurheartj/ehm153. Epub 2007 May 5.

    PMID: 17483538BACKGROUND

  • Monserrat L, Gimeno-Blanes JR, Marin F, Hermida-Prieto M, Garcia-Honrubia A, Perez I, Fernandez X, de Nicolas R, de la Morena G, Paya E, Yague J, Egido J. Prevalence of fabry disease in a cohort of 508 unrelated patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2007 Dec 18;50(25):2399-403. doi: 10.1016/j.jacc.2007.06.062.

    PMID: 18154965BACKGROUND

  • Fauler G, Rechberger GN, Devrnja D, Erwa W, Plecko B, Kotanko P, Breunig F, Paschke E. Rapid determination of urinary globotriaosylceramide isoform profiles by electrospray ionization mass spectrometry using stearoyl-d35-globotriaosylceramide as internal standard. Rapid Commun Mass Spectrom. 2005;19(11):1499-506. doi: 10.1002/rcm.1948.

    PMID: 15880667BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Fabry DiseaseHypertrophy, Left VentricularHypertrophy

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism DisordersCardiomegalyHeart DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Gerald Mundigler, MD

    Medical University of Vienna, Dept. Internal Medicine, Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations

AU(1)