Skip to main content
OpenTrials
Completed

NCT Number: NCT00964782

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fontan Circulation

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Sildenafil

Drug

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.

Other names: Viagra

Placebo

Drug

Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.

Other names: Ora-sweet and Ora-plus (1:1 ratio).

Sildenafil 2

Drug

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).

Other names: Viagra

Placebo 2

Drug

Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Other names: Ora-sweet and Ora-plus (1:1 ratio).

Primary outcomes

  1. The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)

    Time frame: baseline to 1 hour

    A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test

  2. The Change in Exercise Capacity Measured Via Exercise Time

    Time frame: baseline to 1 hour

    A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test

Secondary outcomes

  1. The Change in Exercise Capacity Measured Via Maximum Heart Rate

    Time frame: Baseline to 1 Hour

    A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test

  2. The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.

    Time frame: Baseline to 1 Hour

    A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test

  3. The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).

    Time frame: Baseline to 1 hour

    A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Children's Miracle Network

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2009
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.