Status:
TERMINATED
The Assessment of Right Ventricular Contractility in Response to Sildenafil
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Hypertension
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief 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 hyperte...
Detailed Description
The effectiveness of Sildenafil as a pulmonary vasodilator in children with heart disease was first reported in detail during cardiac catheterization and postoperatively in 2003. It is now used freque...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00742014
Start Date
August 1 2008
End Date
August 1 2011
Last Update
April 19 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada