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

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Fontan Circulation

Treatments: Drug: Placebo 2; Drug: Sildenafil; Drug: Sildenafil 2; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00964782

31171

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Sildenafil crossover to placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Sildenafil

Drug: Placebo 2

Placebo crossover to sidenafil

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Sildenafil 2