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Sponsors and Collaborators: |
St. Michael's Hospital, Toronto University of Toronto |
Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00334490 |
Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery. Several treatments have been used to treat and reduce post operative pulmonary hypertension. Unfortunately none of these treatments are approved for use in this condition and only one (inhaled nitric oxide) is specific enough to pulmonary hypertension to not cause dangerous low blood pressure in the rest of the body. Sadly, inhaled nitric oxide is difficult and expensive to use, and can cause lung damage. Sildenafil citrate is quite specific to the lung vessels, is easy to administer and does not easily cause low blood pressure in other areas of the body. We hypothesize that oral sildenafil 12.5mg will decrease the baseline (pre-dose) mPAP by at least 20% compared with a placebo.
Condition | Intervention | Phase |
Pulmonary Hypertension |
Drug: Sildenafil (Viagra) |
Phase II |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | High Blood Pressure Pulmonary Hypertension |
ChemIDplus related topics: | Sildenafil citrate Sildenafil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double Blind Randomized Controlled Trial to Determine the Safety and Efficacy of 12.5mg of Oral Sildenafil (Viagra) Compared to Placebo to Decrease Pulmonary Hypertension in Cardiac Patients After Cardiopulmonary Bypass |
Estimated Enrollment: | 40 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | June 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
POST-OPERATIVELY
Exclusion Criteria:
POST-OPERATIVELY
Contact: David Mazer, MD | 416-864-5825 | mazerd@smh.toronto.on.ca |
Contact: Doug G. Michaud, H.B.Sc. | 416-864-6060 ext 2920 | michaudd@smh.toronto.on.ca |
Canada, Ontario | |||||
St. Michael's Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5B 1W8 | |||||
Principal Investigator: David Mazer, MD |
St. Michael's Hospital, Toronto |
University of Toronto |
Principal Investigator: | David Mazer, MD | St. Michael's Hospital, Toronto |
Study ID Numbers: | 091532, REB 04-093 |
First Received: | June 6, 2006 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00334490 |
Health Authority: | Canada: Health Canada |
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