Investigating kidney involvement in Fabry disease using MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Caroline M Kistorp, Professor — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Caroline M Kistorp, Professor
• Email: caroline.michaela.kistorp@regionh.dk
• Phone: 35 45 96 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.