Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01548950
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2012-03-05
Brief Title:
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension PAH-CHD
Status:
COMPLETED
Status Verified Date:
2015-06
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:
The purpose of this study is to test the hypothesis that treating PAH-CHD patients preoperatively with PAH drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the risk of residual PAH at six months following operation to 10
Detailed Description:
Pulmonary arterial hypertension PAH is a complicating factor in the management of congenital heart disease CHD with intracardiac or extracardiac communications In children with moderate to severe PAH the risk of serious complications following the surgical repair of shunts including right cardiac failure and death is 15-20 or even higher and the risk of late postoperative residual PAH is 25 We therefore intend to conduct a study aimed at reducing the risk of severe immediate postoperative complications and the risk of residual PAH at six months following surgery to less than 10 in children with moderate PAH primary objective The study is also aimed at promoting a statistically significant reduction in pulmonary artery pressure and pulmonary vascular resistance at six month after surgery compared with baseline in children with moderate or severe PAH secondary objective We hypothesized that these goals could be achieved by treating patients preoperatively and for six months postoperatively with sildenafil either singly or combined with bosentan Both drugs have been approved for treatment of PAH on the basis of randomized clinical trials Preoperative and postoperative on treatment hemodynamic evaluation will be based on noninvasive and invasive diagnostic procedures As an additional objective we intend to analyze possible abnormalities in genes that have been shown to be associated with PAH-CHD and inflammatory mediators as well The idea is to investigate whether changes in these markers correlate with the clinical profile and response to treatments
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