Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 4:09 PM
Study NCT ID:
NCT01481350
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2011-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery
Sponsor:
University of Turin, Italy
Organization:
Study Overview
Official Title:
Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2014-12
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:
SiPaHCS
Brief Summary:
Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.
Detailed Description:
Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.
Study Oversight
Has Oversight DMC:
False
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?: