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NCT05699265 · ClinicalTrials.gov registry record
Cardiovasculorenal Phenotyping in Fabry Disease Through Noninvasive Testing
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- 4
- Enrollment target
NCT05699265: Clinical Trial study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT05699265 is a clinical trial that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05699265 was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
The mean peak systolic blood pressure for Fabry disease patients is assumed to be 160 mmHg
Interventions
- DIAGNOSTIC_TEST Cardiopulmonary exercise testing (CPET)
- DIAGNOSTIC_TEST Measures of arterial stiffness and endothelial function
- DIAGNOSTIC_TEST Ambulatory blood pressure monitoring
- DIAGNOSTIC_TEST Serum and urine biomarkers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2025-04-01 |
Why NCT05699265 stopped before completion
NCT05699265 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Cardiopulmonary exercise testing (CPET) is the first listed.
NCT05699265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05699265 about?
NCT05699265 is a clinical study titled "Cardiovasculorenal Phenotyping in Fabry Disease Through Noninvasive Testing". 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 the...
What is the current status of trial NCT05699265?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2023-02-01. Estimated completion is 2025-04-01.
What interventions are being tested in trial NCT05699265?
The interventions under investigation include: Cardiopulmonary exercise testing (CPET) (DIAGNOSTIC_TEST), Measures of arterial stiffness and endothelial function (DIAGNOSTIC_TEST), Ambulatory blood pressure monitoring (DIAGNOSTIC_TEST), Serum and urine biomarkers (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05699265?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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