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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

Other:placeboPatient will receive a look-alike placebo

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.

SildenafilSildenafil dosage will be 0.5mg/kg (max 20mg)

placeboPatient will receive a look-alike placebo

Study Status

Unknown status

Start Date: August 2009

Completed Date: August 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: An increase in exercise capacity for patients administered sildenafil

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Devyani Chowdhury, MD

Lead Sponsor: Penn State University

Collaborator: Children's Miracle Network

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

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