Upright Versus Supine Exercise Testing in Fontan-palliated Patients

Fontan Palliation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633815
• Other study ID #: HUM00007190
• Status: Completed
• Phase: N/A
• First received: March 4, 2008
• Last updated: May 9, 2017
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fontan Palliation

Intervention

Other:
• Supine positioning
Subjects underwent exercise testing on a stationary bicycle in the supine position
• Upright positioning
Subjects underwent exercise testing on a stationary bicycle in the upright position

Locations

Country	Name	City	State
United States	University of Michigan Health Systems, Pediatric Cardiology	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity	Watts	40 minutes
Secondary	Peak Oxygen Volume (Peak VO2)	milliliters per kilogram of body weight per minute (ml/kg/min)	40 minutes
Secondary	Peak Heart Rate	beats per minute	40 minutes
Secondary	Peak Pulmonary Artery Pressure	millimeters of mercury (mmHg)	40 minutes