Upright Versus Supine Exercise Testing in Fontan-palliated Patients

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00633815
First received: March 4, 2008
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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
Fontan Palliation
Other: Supine and upright positioning

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: Single day testing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Many exercise parameters, including peak VO2, HR, BP, others [ Time Frame: single day testing ] [ Designated as safety issue: No ]

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
Fontan patients Other: Supine and upright positioning
Subjects will undergo exercise testing in both the supine and upright positions
Healthy controls Other: Supine and upright positioning
Subjects will undergo exercise testing in both the supine and upright positions

  Eligibility

Ages Eligible for Study:   8 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

Inclusion Criteria:

  • S/p Fontan palliation > 2 years prior
  • Age 8 to 30

Exclusion Criteria:

  • Pacemaker dependence
  • Severe hypoxemia (O2 saturation <80%)
  • Recent atrial flutter or other arrhythmias
  • Protein losing enteropathy (PLE)
  • Severe atrioventricular valve regurgitation
  • History of cardiac arrest
  • Significant comorbidities (renal failure, asthma, etc).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633815

Locations
United States, Michigan
University of Michigan Health Systems, Pediatric Cardiology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Bryan Goldstein, MD (PI), University of Michigan
ClinicalTrials.gov Identifier: NCT00633815     History of Changes
Other Study ID Numbers: HUM00007190
Study First Received: March 4, 2008
Last Updated: September 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Supine
Upright

ClinicalTrials.gov processed this record on July 23, 2014