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Upright Versus Supine Exercise Testing in Fontan-palliated Patients

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University of Michigan

Status

Completed

Conditions

Fontan Palliation

Treatments

Other: Upright positioning
Other: Supine positioning

Study type

Observational

Funder types

Other

Identifiers

NCT00633815
HUM00007190

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

8 to 30 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

45 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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