Upright Versus Supine Exercise Testing in Fontan-palliated Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Fontan Palliation
• Intervention / Treatment: Other: Supine positioning; Other: Upright positioning

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health Systems, Pediatric Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Watts	40 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: March 4, 2008
• First Posted (Estimate): March 12, 2008

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Upright; Supine
• Other Study ID Numbers: HUM00007190

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No