Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01517854
Status:
TERMINATED
Last Update Posted:
2019-09-27
First Post:
2011-12-14
Brief Title:
Revatio Portal-Pulmonary Arterial Hypertension Trial
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Revatio Portal-Pulmonary Arterial Hypertension Trial RePo1 Trial A Randomized Double-blinded Placebo-controlled Multi-center Study to Evaluate the Effects of Sildenafil Citrate Revatio 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension PPAH
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RePo1
Brief Summary:
The investigators propose the first prospective double blind randomized controlled trial of treatment for pulmonary arterial hypertension PAH related to underlying portal hypertension Specifically the investigators will evaluate the potential efficacy and safety of sildenafil Revatio in a 16 week blinded multicentre study
Detailed Description:
PAH is a recognized complication of portal hypertension - termed portal-pulmonary hypertension PPHTN In the World Health Organization WHO classification PPHTN is categorized as a WHO group 1 condition This categorization is appropriate as PPHTN shares similar pathological features and clinical presentation and as idiopathic primary pulmonary arterial hypertension PAH Advances in oral therapies in PAH idiopathic connective tissue disease congenital heart disease has deferred the need for parenteral therapies lung transplantation and led to improvements in functional capacity quality of life and survival However unlike other forms of PAH treatment options have not been formally evaluated for PPHTN and there are no approved medical therapies Patients are unable to pay for medications Consequently patients continue to endure the natural progression of PAH - a state characterized by progressive right heart failure disability and death Furthermore the unacceptable mortality associated with liver transplantation in the presence of hemodynamically significant PAH leaves them with no therapeutic options Therefore new treatment options need to be systematically evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None