Status:
UNKNOWN
Reversibility by Sildenafil of Exercise-Induced Abnormal Right Ventricular Pressure Response in ASD and VSD-Operated Patients
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Norwegian Foundation for Health and Rehabilitation
Pfizer
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
16-25 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether oral sildenafil citrate reduces the abnormal right ventricular pressure response during exercise in adolescent and adult patients with specific types ...
Detailed Description
13.3 Study design and protocol 13.3.1 Design: double-blind case-control cross-over study 13.3.2 Patients inclusion / exclusion criteria: The study consists of 12-16 patients from the main study (se...
Eligibility Criteria
Inclusion
- Exercise right ventricular systolic pressure of 45 mm Hg or above.
- Operated for atrial septal defect or ventricular septal defect or minimal defect not operated or minimal residual defect.
Exclusion
- Acute infectious/febrile illness,
- Significant mental or physical disability preventing reliable exercise testing
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00772135
Start Date
September 1 2008
End Date
April 1 2009
Last Update
October 15 2008
Active Locations (1)
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1
Rikshospitalet University Hospital
Oslo, Oslo County, Norway, 0027