Upright Versus Supine Exercise Testing in Fontan-palliated Patients

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00633815
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fontan Palliation	Other: Supine positioning; Other: Upright positioning

Study Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• 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
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Exercise Capacity [40 minutes]

   Watts

Secondary Outcome Measures

1. Peak Oxygen Volume (Peak VO2) [40 minutes]

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

2. Peak Heart Rate [40 minutes]

   beats per minute

3. Peak Pulmonary Artery Pressure [40 minutes]

   millimeters of mercury (mmHg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health Systems, Pediatric Cardiology	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bryan Goldstein, Fellow, Pediatric Cardiology, University of Michigan
• ClinicalTrials.gov Identifier: NCT00633815
• Other Study ID Numbers: HUM00007190
• First Posted: Mar 12, 2008
• Last Update Posted: May 10, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bryan Goldstein, Fellow, Pediatric Cardiology, University of Michigan: Supine; Upright

Study Results

No Results Posted as of May 10, 2017