Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01051960
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2010-01-19
Brief Title:
Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan A Prospective Single Center Open Label Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-10
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 determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertension PAH with scleroderma
Detailed Description:
The current literature addresses therapies for patients with resting PAH only diagnosed by right heart catheterization However the World Health Organization WHO also recognizes and defines exercise induced pulmonary arterial hypertension ex-PAH which may precede the development of resting PAH The natural progression of PAH especially during exercise has not been well delineated An exercise hemodynamic study previously showed that in normal healthy subjects the mean pulmonary pressure does not exceed 30mmHg even at maximal cardiac outputs A prior study evaluated exercise Doppler echocardiography systemic sclerosis patients with normal resting echocardiograms finding an abnormal response which was defined as an estimated right ventricular systolic pressure greater than 40 mmHg In the same study 66 of the patients progressed to resting PAH over the followup period of 12 months Limited data is available regarding the prevalence of ex-PAH in systemic sclerosis using right heart catheterization
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