NCT06776419Recruiting
the Role of cArdiac Inflammation, endoThelial Dysfunction, and FIbrosis in fabrY Disease
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 54 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Caroline Michaela Kistorp
- Diseases
- Fabry disease
- NCT number
- NCT06776419
What you commit to
- Study type: Observational
- Planned participants: 54
- From 1 May 2025 to the primary completion date, 1 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared MR compatible.
- Known heart failure, previous apoplexy or previously established kidney disease.
- Initiation or change of antihypertensive therapy within 3 months of enrollment.
- Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared MR compatible.
Other illness
- Any contraindication against a pharmacologically induced rest-stress PET/CT protocol according to local safety procedures such as acute coronary syndrome, severe bronchospasm, severe chronic obstructive pulmonary disease, cardiac arrhythmia.
- A genetically-verified diagnosis of Fabry disease.
- Family member to a patient with a genetically-verified diagnosis of Fabry disease
- Cancer expected to influence life expectancy.
- Any contraindication for a pharmacologically induced stress PET/CT protocol according to local safety procedures such as acute coronary syndrome, severe bronchospasm, severe chronic obstructive pulmonary disease, cardiac arrhythmia.
Age
- Pregnancy
- Age and sex-matched healthy controls (2)
Other
- Known LVH as evaluated on echocardiography
- Pregnancy
Who the study is looking for
- Male and female individuals with a genetically-verified diagnosis of Fabry disease
- ≥ 18 years of age
- Able to give informed consent
- ≥ 18 years of age
- Able to give informed consent
Criteria the registry did not label
- Patients with Fabry disease (1)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.