Sildenafil in Single Ventricle Patients
Information source: Duke University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease
Intervention: Sildenafil by injection (Drug); Sildenafil by injection (Drug); Sildenafil by injection (Drug); Sildenafil by injection (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Kevin D Hill, MD, Principal Investigator, Affiliation: Duke University
Overall contact:
Kevin D Hill, MD, Phone: 919 681 2880, Email: kevin.hill@duke.edu
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 resistance. While surgical outcomes have improved, the physiology of the
single ventricle palliation results in continued long term attrition. Elevated pulmonary
vascular resistance and impaired systemic ventricular function are important risk factors
for failure of single ventricle palliation.
Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in
the pressure overloaded right ventricle.
The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of
sildenafil in single ventricle patients following stage II and III surgical palliation.
Clinical Details
Official title: Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sildenafil pharmacokinetics
Secondary outcome: Hemodynamic safety and efficacy
Eligibility
Minimum age: 3 Months.
Maximum age: 120 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age ≥ 3 months; ≤120 months.
2. History of congenital heart disease with severe hypoplasia of a right or left
ventricle.
3. Undergoing cardiac catheterization as part of standard clinical care.
4. Availability and willingness of the parent/legally authorized representative to
provide written informed consent.
Exclusion Criteria:
1. History of serious adverse event related to sildenafil administration.
2. History of sildenafil exposure within 48 hours of the study.
3. Presence of pulmonary venous obstruction.
4. Treatment with organic nitrates or alpha blockade therapy.
5. Contraindication to cardiac catheterization as determined by the attending
cardiologist and including:
1. Significant hemodynamic instability.
2. Sepsis.
3. Need for ECMO support.
4. Venous occlusion precluding adequate access.
5. Recent systemic illness.
6. Renal failure defined as serum creatinine > 2 times higher than the upper limit of
normal.
7. Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase >
3 times higher than the upper limit of normal.
8. Thrombocytopenia defined as a platelet count < 50 000 cells/µL.
9. Leukopenia defined as white blood cells < 2500 cells/µL.
Locations and Contacts
Kevin D Hill, MD, Phone: 919 681 2880, Email: kevin.hill@duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Kevin D Hill, MD, Phone: 919-681-2880, Email: kevin.hill@duke.edu
Kevin D Hill, MD, Principal Investigator
Additional Information
Starting date: March 2011
Last updated: November 30, 2012
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