Status:

COMPLETED

The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Lead Sponsor:

Milton S. Hershey Medical Center

Collaborating Sponsors:

Children's Miracle Network

Conditions:

Fontan Circulation

Eligibility:

All Genders

6-17 years

Phase:

PHASE4

Brief Summary

The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.

Eligibility Criteria

Inclusion

  • Age 6-17 years
  • Male or female
  • Possess Fontan Circulation

Exclusion

  • Severe heart failure (New York Heart Ass. functional class IV)
  • Evidence of Fontan pathway obstruction
  • History of exercise-induced severe arrhythmias
  • Pregnancy (known or suspected)
  • Orthopedic limitations that prevent ambulation on a treadmill
  • Use of nitroglycerin
  • Herbal medications

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 24 2012

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT00964782

Start Date

August 1 2009

End Date

May 24 2012

Last Update

March 26 2019

Active Locations (1)

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033