Overview
The Assessment of Right Ventricular Contractility in Response to Sildenafil
Status:
Terminated
Terminated
Trial end date:
2011-08-01
2011-08-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The Hospital for Sick ChildrenTreatments:
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