Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377455
Status:
TERMINATED
Last Update Posted:
2018-05-24
First Post:
2006-09-14
Brief Title:
Placebo Controlled Trial of Bosentan in Scleroderma Patients
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class III Scleroderma Patients With Exercise Induced Pulmonary Hypertension
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to inadequate enrolment
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 whether the drug Bosentan improves exercise tolerance in scleroderma patients
Detailed Description:
Pulmonary hypertension PAH is a common and usually fatal form of lung disease in systemic sclerosis SSc Multiple drugs have been approved for the treatment of New York Heart Association NYHAClass IIIIV PAH in scleroderma Bosentan is an endothelin-1 antagonist which showed significant improvement in distance walked during 12 week clinical trials in PAH patients 7 Therapy for asymptomatic systemic sclerosis patients diagnosed incidentally with PAH World Health Organization WHO Functional Class I remains controversial We hypothesize that asymptomatic or minimally symptomatic patients with systemic sclerosis and normal resting pulmonary artery pressures who demonstrate an abnormal rise in pulmonary artery systolic pressure with stress Doppler echocardiography testing represent a subset of patients who already have pulmonary vascular disease and who are at risk for the development of severe PAH We further hypothesize that early identification and treatment of such patients may retard the progression of that disease
Hypotheses
1 Stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis
2 Treatment of exercise-induced PAH with Bosentan will lead to improved exercise endurance in patients with systemic sclerosis
Subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study Exercise Echocardiograms in Scleroderma IRB 03-363
Hypotheses
1 Stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis
2 Treatment of exercise-induced PAH with Bosentan will lead to improved exercise endurance in patients with systemic sclerosis
Subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study Exercise Echocardiograms in Scleroderma IRB 03-363
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Bosentan | OTHER | Georgetown University | None |