NCT00633815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

March 4, 2008

Last Update Submit

May 9, 2017

Conditions

Fontan Palliation

Keywords

SupineUpright

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Watts

    40 minutes

Secondary Outcomes (3)

  • Peak Oxygen Volume (Peak VO2)

    40 minutes

  • Peak Heart Rate

    40 minutes

  • Peak Pulmonary Artery Pressure

    40 minutes

Study Arms (2)

Fontan patients

Subjects will undergo exercise testing in both the supine and upright positions

Other: Supine positioningOther: Upright positioning

Healthy controls

Subjects will undergo exercise testing in both the supine and upright positions

Other: Supine positioningOther: Upright positioning

Interventions

Supine positioningOTHER

Subjects underwent exercise testing on a stationary bicycle in the supine position

Fontan patientsHealthy controls
Upright positioningOTHER

Subjects underwent exercise testing on a stationary bicycle in the upright position

Fontan patientsHealthy controls

Eligibility Criteria

Age8 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • S/p Fontan palliation \> 2 years prior
  • Age 8 to 30 years

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health Systems, Pediatric Cardiology

Ann Arbor, Michigan, 48109, United States

Location

Related 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(8):1169-75. doi: 10.1016/j.amjcard.2009.12.020. Epub 2010 Feb 20.

    PMID: 20381672RESULT

MeSH Terms

Conditions

Deception

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Pediatric Cardiology

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)