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NCT03853837 · ClinicalTrials.gov registry record
Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 32
- Enrollment target
NCT03853837: Completed study, sponsored by Mayo Clinic.
NCT03853837 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03853837 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology. Aim #3: Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction.
Primary Outcome
Fontan associated liver disease measured via magnetic resonance elastography to find liver stiffness measured in kiloPascals: \<2.5kPa = Normal; 2.5 to 3.0 kPa = Normal or inflammation; 3.0 to 3.5 kPa = Stage 1-2 fibrosis; 3.5 to 4 kPa = Stage 2-3 fibrosis; 4 to 5 kPa = Stage 3-4 fibrosis; \>5 kPa = Stage 4 fibrosis;
Interventions
- DIAGNOSTIC_TEST rest-exercise echocardiography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-08-30 |
| Est. Completion | 2022-07-21 |
What the finished NCT03853837 record still lists
NCT03853837 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which rest-exercise echocardiography is the first listed.
NCT03853837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03853837 about?
NCT03853837 is a clinical study titled "Ventricular and Pulmonary Vascular Reserve After the Fontan Operation". Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physi...
What is the current status of trial NCT03853837?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2018-08-30. Estimated completion is 2022-07-21.
What interventions are being tested in trial NCT03853837?
The interventions under investigation include: rest-exercise echocardiography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03853837?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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