Investigating kidney involvement in Fabry disease using MRI
Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
This study is testing a new MRI method to see how Fabry disease affects kidney function by looking at oxygen levels in the kidneys compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06325488 on ClinicalTrials.gov |
What this trial studies
This study aims to explore renal organ involvement in patients with Fabry disease through a novel magnetic resonance imaging (MRI) technique that assesses changes in kidney oxygen levels. It will utilize blood oxygenation-level dependent (BOLD) imaging to evaluate renal oxygenation and correlate it with biomarkers of inflammation, fibrosis, and kidney injury. The study will include both Fabry patients and healthy controls to provide comparative insights into the disease's impact on renal function.
Who should consider this trial
Good fit: Ideal candidates include male and female individuals aged 18 and older diagnosed with Fabry disease.
Not a fit: Patients with contraindications for MRI or those with conditions that significantly affect kidney function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of kidney involvement in Fabry disease, leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: While studies on Fabry disease exist, the specific use of BOLD MRI for assessing renal oxygenation in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Fabry patients: Inclusion Criteria: * Male and female individuals (≥18 years of age) * Able to give informed consent Exclusion Criteria: * Any contraindication for magnetic resonance imaging 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. * Pregnancy Control group Inclusion criteria * Male and female individuals (≥18 years of age) * Able to give informed consent Exclusion criteria * 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. * Known heart failure, previous apoplexia or previously established kidney disease. * Initiation or change of antihypertensive therapy within 3 months of enrolment * Renal impairment as depicted by the CKD-EPI classification (≥ CKD G2/A1) * 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. * Pregnancy
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Caroline M Kistorp, Professor — Rigshospitalet, Denmark
- Study coordinator: Caroline M Kistorp, Professor
- Email: caroline.michaela.kistorp@regionh.dk
- Phone: 35 45 96 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.