Clinical trial NCT00633815: Upright Versus Supine Exercise Testing in Fontan-palliated Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fontan Palliation
Keywords: Supine
Upright
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Exercise Capacity
timeFrame: 40 minutes
Secondary outcomes:
measure: Peak Oxygen Volume (Peak VO2)
timeFrame: 40 minutes
measure: Peak Heart Rate
timeFrame: 40 minutes
measure: Peak Pulmonary Artery Pressure
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems, Pediatric Cardiology
state: Michigan
Study officials:
References:
citation: Goldstein BH, Connor CE, Gooding L, Rocchini AP. Relation of systemic venous return, pulmonary vascular resistance, and diastolic dysfunction to exercise capacity in patients with single ventricle receiving fontan palliation. Am J Cardiol. 2010 Apr 15;105(8):1169-75. doi: 10.1016/j.amjcard.2009.12.020. Epub 2010 Feb 20.