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.

Study Overview

• Status: Completed
• Conditions: Fontan Circulation
• Intervention / Treatment: Drug: Sildenafil; Drug: Placebo 2; Drug: Placebo; Drug: Sildenafil 2

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sildenafil crossover to placebo; Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2, placebo drug administered before the exercises.	Drug: Sildenafil; 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; Drug: Placebo 2; 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).
Placebo Comparator: Placebo crossover to sidenafil; Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2 Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.	Drug: Placebo; 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).; Drug: Sildenafil 2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)	A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test	baseline to 1 hour
The Change in Exercise Capacity Measured Via Exercise Time	A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test	baseline to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change in Exercise Capacity Measured Via Maximum Heart Rate	A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test	Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.	A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test	Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).	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	Baseline to 1 hour

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Children's Miracle Network
• Investigators: Principal Investigator: Devyani Chowdhury, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 24, 2012
• Study Completion (Actual): May 24, 2012

Study Registration Dates

• First Submitted: August 21, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: exercise capacity; sildenafil; Fontan; Patients with Fontan Circulation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: 31171

Drug and device information, study documents

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