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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 April 2021 |
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Main ID: |
NCT00742014 |
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Date of registration:
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25/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Assessment of Right Ventricular Contractility in Response to Sildenafil
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Scientific title:
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The Assessment of Right Ventricular Contractility in Response to Sildenafil in Pediatric Patients With Pulmonary Arterial Hypertension |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00742014 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Andrew Redington, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: Sildenafil
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Primary Outcome(s)
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Increase (% change) in endsystolic elastance of the right ventricle from baseline (in comparison to change in endsystolic elastance after inhaled NO)
[Time Frame: 30 mins after Sildenafil adminsitration]
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Secondary ID(s)
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1000012265
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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