Upright Versus Supine Exercise Testing in Fontan-palliated Patients

Completed

• Conditions: Fontan Palliation
• Interventions: Other: Supine positioning; Other: Upright positioning

• Registration Number: NCT00633815
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-12
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Exercise Capacity	40 minutes	Watts

Secondary Outcome Measures

Name	Time	Method
Peak Pulmonary Artery Pressure	40 minutes	millimeters of mercury (mmHg)
Peak Oxygen Volume (Peak VO2)	40 minutes	milliliters per kilogram of body weight per minute (ml/kg/min)
Peak Heart Rate	40 minutes	beats per minute

Trial Locations

Locations (1)

University of Michigan Health Systems, Pediatric Cardiology; 🇺🇸 Ann Arbor, Michigan, United States