Prospective Monocentric Cohort Study to Evaluate Predictors for Heart Failure and Sudden Cardiac Death in Patients With Fabry Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rare Diseases
- Sponsor
- Wuerzburg University Hospital
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Cardiac death
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as well as terminal heart failure in patients with Fabry disease.
Detailed Description
Fabry disease is a rare disease and part of the group of lysosomal storage disorders. Natural history of Fabry disease has proven poor survival to ages \>50 years outlining the importance to evaluate cardiac symptoms and outcomes of patients with Fabry disease. This study is a prospective cohort study and observes patients since 2001. Through this long-term experience and the relative high number of patients this study is suggested to help estimating the risk of cardiac arrhythmias and sudden cardiac death (SCD) as well as death or heart transplantation due to terminal heart failure. All patients in treatment in the Fabry Center Wuerzburg (FAZiT) are included in this study if informed consent is provided.
Investigators
PD Dr. Peter Nordbeck
Head Consultant Cardiology and Chief of Electrophysiology
Wuerzburg University Hospital
Eligibility Criteria
Inclusion Criteria
- •Fabry disease (genetically confirmed)
- •Signed informed consent
- •18 years and older
Exclusion Criteria
- •No informed consent
- •Withdrawal of informed consent
Outcomes
Primary Outcomes
Cardiac death
Time Frame: From date of inclusion until the date of first documented event, up to the year 2032
Patients sustaining cardiac death
Secondary Outcomes
- Heart transplantation(From date of inclusion until the date of first documented event, up to the year 2032)
- Malign Arrhythmias(From date of inclusion until the date of death, up to the year 2032)