Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334490
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2006-06-06
Brief Title:
Does Oral Sildenafil Viagra Decrease Mean Pulmonary Artery Pressure After Cardiac Surgery
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Phase II Double Blind Randomized Controlled Trial to Determine the Safety and Efficacy of 125mg of Oral Sildenafil Viagra Compared to Placebo to Decrease Pulmonary Hypertension in Cardiac Patients After Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 125mg will decrease the baseline pre-dose mPAP by at least 20 compared with a placebo
Detailed Description:
Sildenafil citarte is a selective pulmonary vasodilator without profound effects on systemic hemodynamics making it an attractive option for treating post operative pulmonary hypertension in the cardiac surgical patients It is inexpensive and feasible to administer Intravenous as well as oral doses have been shown to reduce the mean pulmonary arterial pressure mPAP and pulmonary vascular resistance PVR in animal models as well as in clinical trials with adults with primary pulmonary hypertension and children after cardiac surgery However no data exists to support the safety and efficacy of Sildenafil citrate in the adult cardiac surgical population The purpose of this study is to further investigate the potential role of Sildenafil citrate to treat post operative pulmonary hypertension in the cardiac population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REB 04-093 | OTHER | St Michaels Hospital Toronto | None |