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Upright Versus Supine Exercise Testing in Fontan-palliated Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633815
First Posted: March 12, 2008
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bryan Goldstein, University of Michigan
  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 positioning Other: 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 Bryan Goldstein, University of Michigan:

Primary Outcome Measures:
  • Exercise Capacity [ Time Frame: 40 minutes ]
    Watts


Secondary Outcome Measures:
  • Peak Oxygen Volume (Peak VO2) [ Time Frame: 40 minutes ]
    milliliters per kilogram of body weight per minute (ml/kg/min)

  • Peak Heart Rate [ Time Frame: 40 minutes ]
    beats per minute

  • Peak Pulmonary Artery Pressure [ Time Frame: 40 minutes ]
    millimeters of mercury (mmHg)


Enrollment: 45
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fontan patients
Subjects will undergo exercise testing in both the supine and upright positions
Other: Supine positioning
Subjects underwent exercise testing on a stationary bicycle in the supine position
Other: Upright positioning
Subjects underwent exercise testing on a stationary bicycle in the upright position
Healthy controls
Subjects will undergo exercise testing in both the supine and upright positions
Other: Supine positioning
Subjects underwent exercise testing on a stationary bicycle in the supine position
Other: Upright positioning
Subjects underwent exercise testing on a stationary bicycle in the upright position

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 years

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Bryan Goldstein, Fellow, Pediatric Cardiology, University of Michigan
ClinicalTrials.gov Identifier: NCT00633815     History of Changes
Other Study ID Numbers: HUM00007190
First Submitted: March 4, 2008
First Posted: March 12, 2008
Last Update Posted: May 10, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bryan Goldstein, University of Michigan:
Supine
Upright


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