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Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease

RecruitingN/A

Sponsor: Caroline Michaela Kistorp

Conditions: Fabry Disease, Chronic Kidney Diseases

Countries: Denmark

The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls. The study will achieve this by: 1\) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney. 2\) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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

Locations (1)

Copenhagen, Denmark