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Completed

NCT Number: NCT01169519

Sildenafil in Single Ventricle Patients

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.

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Key information

Conditions

Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoplastic Left Heart Syndrome

Age range

3 month–120 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil by injection

Drug

Sildenafil 0.125mg/kg injection over 20min

Other names: Revatio

Primary outcomes

  1. Maximum Sildenafil Plasma Concentration

    Time frame: 5 minutes after completion of sildenafil infusion

    Assessment of peak sildenafil plasma concentration.

Secondary outcomes

  1. Hemodynamic Safety and Efficacy

    Time frame: 10 minutes after completion of sildenafil infusion

    Assessment of pulmonary vascular resistance

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2010
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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