The Assessment of Right Ventricular Contractility in Response to Sildenafil

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to examine the effects of Sildenafil, administered during cardiac catheterization, on right ventricular contractility in children with pulmonary arterial hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Significant pulmonary arterial hypertension (mean pulmonary artery pressure > 25 mm Hg)

• Patients aged 4-18 years

• Routine cardiac catheterization clinically indicated for deciding therapeutic treatment

• Informed assent/consent from patient/parent

Exclusion Criteria:

• Suprasystemic pulmonary artery pressures

• Evidence of right heart failure

• History of ventricular arrhythmia

• Known vascular access arrhythmia

• Contraindication to Sildenafil

• Concurrent inotropic / PDE administration

• Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves

• No consent/assent

• Pregnancy or unwillingness to comply with contraceptive advice