Status:
UNKNOWN
Fabry Exercise Intolerance Study
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Fabry Disease
Fabry Disease, Cardiac Variant
Eligibility:
All Genders
18+ years
Brief Summary
Patients and healthy controls will undergo cardiopulmonary exercises and testing of the muscles strength to gain additional understanding of exercise intolerance as Fabry disease (FD) manifestation. A...
Detailed Description
Background: Fabry disease (FD) is an inherited, highly variable and slowly progressive X linked disorder, which predominantly affects vascular endothelium, the heart, kidneys and the brain. Exercise i...
Eligibility Criteria
Inclusion
- FD patients: Men and women with a definite known diagnosis of FD.
- Healthy controls: Healthy control subjects (men and women) with an age of 18 years of older.
Exclusion
- FD patients:
- Pregnancy
- Recent acute myocardial infarct (\<6 months)
- Uncontrolled arrhythmia/severe conduction disorder (atrial fibrillation or second/third-degree AV block) causing hemodynamic compromise
- Implantable pacemaker or other cardiac device with complete ventricular pacing
- Uncontrolled heart failure with hemodynamic compromise
- Uncontrolled hypertension (Systolic Blood Pressure \>150 mmHg and Diastolic Blood Pressure \>100 mmHg on repeated measurements)
- Active infection, anaemia, severe renal dysfunction (estimated Glomerular filtration rate \<30 ml/min/1,73m2) likely to significantly impact on exercise performance
- In some cases: use of anticoagulants or anti platelet therapy (see study procedure)
- Healthy controls:
- All abovementioned exclusion criteria for FD patients
- History of smoking
- History of active drug use which can affect exercise intolerance
- History of asthma, chronic obstructive pulmonary disease, heart failure, heart surgery, heart rhythm disorders or congenital heart diseases
- Use of chronic medication likely to affect exercise tolerance
- Chronic illness (including orthopaedic, endocrinological, haematological, malignant, gastrointestinal, neurological, muscle or inflammatory disorders) likely to significantly impact on exercise performance
- \>6 alcohol units per day or \>14 alcohol units per week
Key Trial Info
Start Date :
October 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 2 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05413876
Start Date
October 10 2021
End Date
January 2 2024
Last Update
August 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ