Sildenafil in Single Ventricle Patients

Phase 1

Completed

• Conditions: Heart Disease
• Interventions: Drug: Sildenafil by injection

• Registration Number: NCT01169519
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Study Start: 2011-04
• Status Verified: 2012-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-07-29
• Results First Submitted QC: 2013-10-10
• Last Update Submitted: 2013-10-10
• Results First Posted: 2013-12-05
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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 Extra-Corporeal Membrane Oxygenation (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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil by injection	Pharmacokinetic and hemodynamic evaluation following sildenafil administration

Primary Outcome Measures

Name	Time	Method
Maximum Sildenafil Plasma Concentration	5 minutes after completion of sildenafil infusion	Assessment of peak sildenafil plasma concentration.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic Safety and Efficacy	10 minutes after completion of sildenafil infusion	Assessment of pulmonary vascular resistance

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States