Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145938
Status:
TERMINATED
Last Update Posted:
2013-10-08
First Post:
2005-09-01
Brief Title:
Sildenafil and Pulmonary Artery Pressure
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Pilot Study of the Effect of Chronic Administration of Sildenafil on Pulmonary Artery Pressure in Patients With Portopulmonary Hypertension
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to complete study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to see if the administration of sildenafil Viagra in patients with portopulmonary hypertension could be a safe and effective treatment
Portopulmonary hypertension PTPH is a special type of pulmonary hypertension Pulmonary hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood from the right ventricle of the heart to the lungs Pulmonary hypertension results from constriction or tightening of the blood vessels that supply blood to the lungs Consequently it becomes difficult for blood to pass through the lungs making it harder for the heart to pump blood forward This stress on the heart leads to enlargement of the heart and eventually fluid can build up in the liver and tissues such as in the legs Affected patients can sometimes notice increasing shortness of breath and dizziness
There is a growing body of evidence suggesting a potential therapeutic role for this sildenafil in patients with primary pulmonary hypertension Studies are ongoing regarding this area
Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery pressures by at least 25 reduction in mean pulmonary artery pressure and could be an effective treatment for PTPH especially in candidates for liver transplantation
Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary arterial pressure in patients with PTPH
Secondary Hypothesis To measure the effects of chronic 3 month treatment with sildenafil on pulmonary arterial pressure safety and tolerability in patients with PTPH
Portopulmonary hypertension PTPH is a special type of pulmonary hypertension Pulmonary hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood from the right ventricle of the heart to the lungs Pulmonary hypertension results from constriction or tightening of the blood vessels that supply blood to the lungs Consequently it becomes difficult for blood to pass through the lungs making it harder for the heart to pump blood forward This stress on the heart leads to enlargement of the heart and eventually fluid can build up in the liver and tissues such as in the legs Affected patients can sometimes notice increasing shortness of breath and dizziness
There is a growing body of evidence suggesting a potential therapeutic role for this sildenafil in patients with primary pulmonary hypertension Studies are ongoing regarding this area
Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery pressures by at least 25 reduction in mean pulmonary artery pressure and could be an effective treatment for PTPH especially in candidates for liver transplantation
Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary arterial pressure in patients with PTPH
Secondary Hypothesis To measure the effects of chronic 3 month treatment with sildenafil on pulmonary arterial pressure safety and tolerability in patients with PTPH
Detailed Description:
This is a single center only takes place at University of Chicago open-label doctor and subject know that the subject is taking the experimental drut pilot study to evaluate the effects of sildenafil on pulmonary artery pressures in patients with portopulmonary hypertension
Patients who are diagnosed with PTPH after having routine care right heart catheterization will be asked if they are interested in participating Approximately ten subjects will be enrolled Subjects will undergo the following experimental procedures as part of their participation in this study blood laboratory tests medical history physical exam inhaled nitric oxide test study drug sildenafil administration and a pill count
Sildenafil will be given to these patients 3 times a day for a 12 week period to see if the study drug can lower their pulmonary artery pressures by at least 25
Patients who are diagnosed with PTPH after having routine care right heart catheterization will be asked if they are interested in participating Approximately ten subjects will be enrolled Subjects will undergo the following experimental procedures as part of their participation in this study blood laboratory tests medical history physical exam inhaled nitric oxide test study drug sildenafil administration and a pill count
Sildenafil will be given to these patients 3 times a day for a 12 week period to see if the study drug can lower their pulmonary artery pressures by at least 25
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