Overview

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