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Sponsored by: |
University of Michigan |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00633815 |
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.
Condition | Intervention |
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Fontan Palliation |
Other: Supine and upright positioning |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Study of Upright Versus Supine Exercise Testing in Fontan-palliated Patients, Compared With Healthy Controls, to Evaluate for Postural Effects on Exercise Parameters |
Enrollment: | 45 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Fontan patients |
Other: Supine and upright positioning
Subjects will undergo exercise testing in both the supine and upright positions
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Healthy controls |
Other: Supine and upright positioning
Subjects will undergo exercise testing in both the supine and upright positions
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Ages Eligible for Study: | 8 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Fontan-palliated patients aged 8-30 will be recruited for this study. Eligible patients will be identified from the cardiology and surgery database here. Patients will be contacted by phone and/or formal letter informing them of the study. If their primary cardiologist is not in our group, a courtesy call will be made or letter sent. Age and gender matched healthy controls will be sought as well through local recruitment (schools, university campus, local community postings).
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Michigan ( Bryan Goldstein, MD (PI) ) |
Study ID Numbers: | HUM00007190 |
Study First Received: | March 4, 2008 |
Last Updated: | September 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00633815 History of Changes |
Health Authority: | United States: Institutional Review Board |
Supine Upright |
Healthy |