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NCT00633815 · ClinicalTrials.gov registry record
Upright Versus Supine Exercise Testing in Fontan-palliated Patients
A clinical trial of Fontan Palliation, sponsored by University of Michigan.
- Completed
- Registry status
- 45
- Enrollment target
- 1
- Study location
NCT00633815: Completed study of Fontan Palliation, sponsored by University of Michigan.
NCT00633815 is a study of Fontan Palliation that has completed, run by University of Michigan. The registered enrollment target is 45 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00633815, a study of Fontan Palliation, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2). Although one recent study demonstrated that Fontan patients can increase their Max VO2 through diligent cardiac rehabilitation, their ultimate results were still well below average. It has previously been described that normal, healthy subjects have decreased exercise performance in a supine vs upright position. However, due to high venous pressures and the need for systemic venous return to overcome gravity in order to perfuse the lungs, one might hypothesize that Fontan patients would have increased exercise performance in a supine vs upright position. The investigators are interested in studying this hypothesis.
Primary Outcome
Watts
Conditions Studied
Interventions
- OTHER Supine positioning
- OTHER Upright positioning
Study Locations (1)
Michigan
- University of Michigan Health Systems, Pediatric Cardiology - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-11 |
What the finished NCT00633815 record still lists
NCT00633815 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 1 condition, with Fontan Palliation appearing as the primary indexed condition, and to 2 interventions - of which Supine positioning is the first listed.
NCT00633815 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT00633815 about?
NCT00633815 is a clinical study titled "Upright Versus Supine Exercise Testing in Fontan-palliated Patients". Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. In addition, thes...
What is the current status of trial NCT00633815?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2008-01. Estimated completion is 2008-11.
What conditions does trial NCT00633815 study?
This clinical trial studies the following conditions: Fontan Palliation.
What interventions are being tested in trial NCT00633815?
The interventions under investigation include: Supine positioning (OTHER), Upright positioning (OTHER).
Who is sponsoring clinical trial NCT00633815?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00633815 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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