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

Fontan Circulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964782
• Other study ID #: 31171
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: May 24, 2012

Study information

• Verified date: March 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 24, 2012
• Est. primary completion date: May 24, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fontan Circulation

Intervention

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.
• 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.
• 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).
• Placebo 2
Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Children's Miracle Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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