Actively Recruiting
the Role of cArdiac Inflammation, endoThelial Dysfunction, and FIbrosis in fabrY Disease
Led by Caroline Michaela Kistorp · Updated on 2025-04-08
54
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
Sponsors
C
Caroline Michaela Kistorp
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overall objective of this study is to investigate Fabry-related cardiomyopathy and the use of native T1-mapping, coronary microvascular function, cardiac inflammation, and cardiac injury in an effort to improve the ability to detect disease. The study aims to achieve this by: 1. Investigating the association between cardiac inflammation, fibrosis, and injury against the distribution and degree of microvascular disease in patients with Fabry disease with and without left ventricular hypertrophy (LVH) using cardiac magnetic resonance (CMR) imaging and 82Rubidium Positron emission tomography and computer tomography (82Rb-PET/CT). 2. Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-related cardiomyopathy.
CONDITIONS
Official Title
the Role of cArdiac Inflammation, endoThelial Dysfunction, and FIbrosis in fabrY Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female individuals with a genetically-verified diagnosis of Fabry disease
- 18 years of age or older
- Able to give informed consent
- Age and sex-matched healthy controls aged 18 years or older
- Healthy controls able to give informed consent
You will not qualify if you...
- Contraindications to pharmacologically induced rest-stress PET/CT such as acute coronary syndrome, severe bronchospasm, severe chronic obstructive pulmonary disease, or cardiac arrhythmia
- Contraindications to MRI including claustrophobia, metallic foreign bodies, metallic implants, internal electrical devices, or non-MR compatible permanent makeup/tattoos
- Pregnancy
- Healthy controls with a genetically-verified diagnosis of Fabry disease or who are family members of such patients
- Healthy controls with cancer expected to influence life expectancy
- Healthy controls with known heart failure, previous stroke, or established kidney disease
- Healthy controls with initiation or change of antihypertensive therapy within 3 months before enrollment
- Healthy controls with known left ventricular hypertrophy as evaluated by echocardiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
C
Caroline Kistorp, Professor
CONTACT
N
Niels Høeg Brandt-Jacobsen, PhD, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here