Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01757808
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2012-04-26
Brief Title:
A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2017-03
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 assess the safety of ranolazine in people with pulmonary arterial hypertension PAH and who are receiving 1 or more background PAH therapies ambrisentan sildenafiltadalafil epoprostenol treprostinil IV SC inhaled or iloprost The primary objective is
To estimate the effect of ranolazine administration on acute hemodynamics
To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after 12 weeks of therapy
To assess changes in right ventricular function after 12 weeks of therapy
To estimate the effect of ranolazine administration on acute hemodynamics
To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after 12 weeks of therapy
To assess changes in right ventricular function after 12 weeks of therapy
Detailed Description:
Pulmonary arterial hypertension is a medical disorder in which pressure in the blood vessels going from the right side of the heart to the lungs is higher than normal The increased blood pressure in the lungs places a strain on the heart This strain causes the heart to pump less blood into the lungs causing physical symptoms of shortness of breath and tiredness The added strain to the heart can cause physical symptoms of swelling in the feet and abdomen These symptoms can get worse over time due to the decreased pumping ability of the heart
This study will use a drug called ranolazine This drug has been approved by the Food and Drug Administration FDA to treat chronic angina chest pain However since it has not been approved for use in PAH its use in this study is considered experimental
This study will use a drug called ranolazine This drug has been approved by the Food and Drug Administration FDA to treat chronic angina chest pain However since it has not been approved for use in PAH its use in this study is considered experimental
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