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

Fontan Circulation research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fontan Circulation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sildenafiloral 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.

Drug:PlaceboPatient 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.

Drug:Sildenafil 2oral 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).

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sildenafil crossover to placeboSildenafil 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.

Placebo crossover to sidenafilPatient 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.

Study Status

Completed

Start Date: August 2009

Completed Date: May 24, 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)

Secondary Outcome: The Change in Exercise Capacity Measured Via Maximum Heart Rate

Study sponsors, principal investigator, and references

Principal Investigator: Devyani Chowdhury, MD

Lead Sponsor: Milton S. Hershey Medical Center

Collaborator: Children's Miracle Network

More information:https://clinicaltrials.gov/show/NCT00964782

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