Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02169752
Status:
TERMINATED
Last Update Posted:
2021-01-19
First Post:
2014-05-06
Brief Title:
Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
Sponsor:
National Jewish Health
Organization:
National Jewish Health
Study Overview
Official Title:
Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left National Jewish Health
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMERICA-PAH
Brief Summary:
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension It is also looking at using right ventricle function changes as a marker of disease severity
Detailed Description:
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension It is also looking at using right ventricle function changes as a marker of disease severity
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are used for pulmonary arterial hypertension It represents a group of patients that are at risk for developing pulmonary arterial hypertension
The administration of ambrisentan is the experimental part of this study Ambrisentan has not been approved by the FDA for use of improving right ventricle function in people with pre-pulmonary arterial hypertension You will still receive your normal clinical care
The purpose of this study is to learn more about ambrisentan and its role in treating systemic sclerosis-associated pre-pulmonary arterial hypertension Ambrisentan is already approved for use in people with systemic sclerosis-associated pulmonary arterial hypertension but this study wants to research its role in people with pre-pulmonary arterial hypertension
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are used for pulmonary arterial hypertension It represents a group of patients that are at risk for developing pulmonary arterial hypertension
The administration of ambrisentan is the experimental part of this study Ambrisentan has not been approved by the FDA for use of improving right ventricle function in people with pre-pulmonary arterial hypertension You will still receive your normal clinical care
The purpose of this study is to learn more about ambrisentan and its role in treating systemic sclerosis-associated pre-pulmonary arterial hypertension Ambrisentan is already approved for use in people with systemic sclerosis-associated pulmonary arterial hypertension but this study wants to research its role in people with pre-pulmonary arterial hypertension
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