Viewing Study NCT05699265



Ignite Creation Date: 2024-05-06 @ 6:31 PM
Last Modification Date: 2024-10-26 @ 2:50 PM
Study NCT ID: NCT05699265
Status: RECRUITING
Last Update Posted: 2024-06-12
First Post: 2023-01-12

Brief Title: Cardiovasculorenal Phenotyping in Fabry Disease Through Noninvasive Testing
Sponsor: Childrens Hospital Medical Center Cincinnati
Organization: Childrens Hospital Medical Center Cincinnati

Study Overview

Official Title: Cardiovasculorenal Phenotyping in Fabry Disease Through Noninvasive Testing
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VDFP
Brief Summary: A longitudinal pilot study will be conducted to determine if there are additional testing modalities that are effective in broadly phenotyping subclinical dysfunction in patients with Fabry disease Individual patients will undergo serial testing over a two-year period to evaluate for changes in their cardiovasculaorenal function during this period Novel modalities evaluated will include measures of arterial stiffness ambulatory blood pressure monitoring cardiopulmonary exercise testing CPET and novel serum and urine biomarkers The benefit of these measures being evaluated is that they are noninvasive can be performed rapidly and have reduced costs compared to the current standard screening modalities Results from these evaluations will be compared to cMRI and standard urine and serum biomarkers performed clinically per local standard of care The results will also be compared to both published normative data and data from patients with diabetes mellitus who have a similar microvascular disease process to patients with Fabry disease
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None