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Clinical Trials/NCT01169519
NCT01169519CompletedPhase 1

Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients

Duke University1 site in 1 country21 target enrollmentStarted: April 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Maximum Sildenafil Plasma Concentration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Months to 120 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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.
  • 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.

Arms & Interventions

Sildenafil

Active Comparator

Pharmacokinetic and hemodynamic evaluation following sildenafil administration

Intervention: Sildenafil by injection (Drug)

Outcomes

Primary Outcomes

Maximum Sildenafil Plasma Concentration

Time Frame: 5 minutes after completion of sildenafil infusion

Assessment of peak sildenafil plasma concentration.

Secondary Outcomes

  • Hemodynamic Safety and Efficacy(10 minutes after completion of sildenafil infusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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