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Sponsors and Collaborators: |
Rikshospitalet HF Norwegian Foundation for Health and Rehabilitation Pfizer |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00772135 |
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 of congenital heart defects.
Condition | Intervention |
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Congenital Heart Disease |
Drug: sildenafil citrate |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Pulmonary Hypertension in Adolescents and Adults With Congenital Heart Disease |
Estimated Enrollment: | 15 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erik Thaulow, professor Dr Med | +47 23074537 | erik.thaulow@rikshospitalet.no |
Contact: Henrik Holmstrom, dr med | +47 23074541 | henrik.holmstrom@rikshospitalet.no |
Norway | |
Rikshospitalet University Hospital | Recruiting |
Oslo, Norway, 0027 | |
Contact: Henrik Brun, MD +4723074554 henrik.brun@rikshospitalet.no | |
Contact: per morten fredriksen, dr scient +4723072277 per.morten.fredriksen@rikshospitalet.no |
Responsible Party: | Foreningen for Hjertesyke Barn ( Steinar Johansen ) |
Study ID Numbers: | RH 2008 HR 2006 / 2 / 0012 TM, 2006 / 2 / 0012 |
Study First Received: | October 14, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772135 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
pulmonary hypertension congenital heart defects exercise phosphodiesterase inhibitors Exercise induced pulmonary arterial hypertensive response in congenital heart disease |
Heart Diseases Cardiovascular Abnormalities Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Citric Acid Sildenafil Congenital Abnormalities Heart Defects, Congenital Hypertension |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |