Status:
COMPLETED
Sildenafil in Single Ventricle Patients
Lead Sponsor:
Duke University
Conditions:
Heart Disease
Eligibility:
All Genders
3-120 years
Phase:
PHASE1
Brief Summary
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular ...
Eligibility Criteria
Inclusion
- Age ≥ 3 months; ≤120 months.
- History of congenital heart disease with severe hypoplasia of a right or left ventricle.
- Undergoing cardiac catheterization as part of standard clinical care.
- Availability and willingness of the parent/legally authorized representative to provide written informed consent.
Exclusion
- History of serious adverse event related to sildenafil administration.
- History of sildenafil exposure within 48 hours of the study.
- Presence of pulmonary venous obstruction.
- Treatment with organic nitrates or alpha blockade therapy.
- Contraindication to cardiac catheterization as determined by the attending cardiologist and including:
- Significant hemodynamic instability.
- Sepsis.
- Need for Extra-Corporeal Membrane Oxygenation (ECMO) support.
- Venous occlusion precluding adequate access.
- Recent systemic illness.
- Renal failure defined as serum creatinine \> 2 times higher than the upper limit of normal.
- Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase \> 3 times higher than the upper limit of normal.
- Thrombocytopenia defined as a platelet count \< 50 000 cells/µL.
- Leukopenia defined as white blood cells \< 2500 cells/µL.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01169519
Start Date
April 1 2011
End Date
December 1 2012
Last Update
December 5 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710