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RECRUITINGOBSERVATIONAL

Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Fabry patients: Who May Qualify: - Male and female individuals (≥18 years of age) - Able to give willing to sign a consent form Who Should NOT Join This Trial: - 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 willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Rigshospitalet
Copenhagen, Denmark