Back to resultsSildenafil in Single Ventricle Patients
Primary Purpose
Heart Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sildenafil by injection
Sildenafil by injection
Sildenafil by injection
Sildenafil by injection
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease focused on measuring Hypoplastic left heart syndrome, Hypoplastic right heart syndrome, Superior cavopulmonary anastomosis, Total cavopulmonary anastomosis, Children with single ventricle anatomy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Sildenafil
Arm Description
Pharmacokinetic and hemodynamic evaluation following sildenafil administration
Outcomes
Primary Outcome Measures
Maximum Sildenafil Plasma Concentration
Assessment of peak sildenafil plasma concentration.
Secondary Outcome Measures
Hemodynamic Safety and Efficacy
Assessment of pulmonary vascular resistance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01169519
Brief Title
Sildenafil in Single Ventricle Patients
Official Title
Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Hypoplastic left heart syndrome, Hypoplastic right heart syndrome, Superior cavopulmonary anastomosis, Total cavopulmonary anastomosis, Children with single ventricle anatomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Active Comparator
Arm Description
Pharmacokinetic and hemodynamic evaluation following sildenafil administration
Intervention Type
Drug
Intervention Name(s)
Sildenafil by injection
Other Intervention Name(s)
Revatio
Intervention Description
Sildenafil 0.125mg/kg injection over 20min
Intervention Type
Drug
Intervention Name(s)
Sildenafil by injection
Other Intervention Name(s)
Revatio
Intervention Description
Sildenafil 0.25mg/kg injection over 20min
Intervention Type
Drug
Intervention Name(s)
Sildenafil by injection
Other Intervention Name(s)
Revatio
Intervention Description
Sildenafil 0.35mg/kg by injection over 20min
Intervention Type
Drug
Intervention Name(s)
Sildenafil by injection
Other Intervention Name(s)
Revatio
Intervention Description
Sildenafil 0.45mg/kg by injection over 20min
Primary Outcome Measure Information:
Title
Maximum Sildenafil Plasma Concentration
Description
Assessment of peak sildenafil plasma concentration.
Time Frame
5 minutes after completion of sildenafil infusion
Secondary Outcome Measure Information:
Title
Hemodynamic Safety and Efficacy
Description
Assessment of pulmonary vascular resistance
Time Frame
10 minutes after completion of sildenafil infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
120 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D Hill, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23823195
Citation
Hill KD, Tunks RD, Barker PC, Benjamin DK Jr, Cohen-Wolkowiez M, Fleming GA, Laughon M, Li JS. Sildenafil exposure and hemodynamic effect after stage II single-ventricle surgery. Pediatr Crit Care Med. 2013 Jul;14(6):593-600. doi: 10.1097/PCC.0b013e31828aa5ee.
Results Reference
result
PubMed Identifier
24201857
Citation
Tunks RD, Barker PC, Benjamin DK Jr, Cohen-Wolkowiez M, Fleming GA, Laughon M, Li JS, Hill KD. Sildenafil exposure and hemodynamic effect after Fontan surgery. Pediatr Crit Care Med. 2014 Jan;15(1):28-34. doi: 10.1097/PCC.0000000000000007.
Results Reference
derived
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Sildenafil in Single Ventricle Patients
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