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OpenTrials
Completed

NCT Number: NCT00633815

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, 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.

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Key information

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Health Systems, Pediatric Cardiology

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Supine positioning

Other

Subjects underwent exercise testing on a stationary bicycle in the supine position

Upright positioning

Other

Subjects underwent exercise testing on a stationary bicycle in the upright position

Primary outcomes

  1. Exercise Capacity

    Time frame: 40 minutes

    Watts

Secondary outcomes

  1. Peak Oxygen Volume (Peak VO2)

    Time frame: 40 minutes

    milliliters per kilogram of body weight per minute (ml/kg/min)

  2. Peak Heart Rate

    Time frame: 40 minutes

    beats per minute

  3. Peak Pulmonary Artery Pressure

    Time frame: 40 minutes

    millimeters of mercury (mmHg)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Study of Upright Versus Supine Exercise Testing in Fontan-palliated Patients, Compared With Healthy Controls, to Evaluate for Postural Effects on Exercise Parameters

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2008
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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