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Sponsors and Collaborators: |
Georgetown University Actelion |
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Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00377455 |
The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.
Condition | Intervention | Phase |
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Systemic Scleroderma Pulmonary Hypertension |
Drug: Bosentan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Placebo Controlled Trial of Bosentan Vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension |
Estimated Enrollment: | 40 |
Study Start Date: | September 2006 |
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 Class III/IV 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 (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:
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Right heart catheterization with
Entry criteria for participating in the exercise echocardiogram study (IRB 03-363)
Exclusion Criteria:
Contact: Virginia D Steen, MD | 202-687-8233 | steenv@georgetown.edu |
Contact: Raymond Foley, MD | 860-679-3585 | rfoley@uchc.edu |
United States, Connecticut | |
University of Connecticut | Recruiting |
Farmington, Connecticut, United States, 06030 | |
Principal Investigator: Raymond Foley, MD | |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Principal Investigator: Virginia D Steen, MD |
Principal Investigator: | Virginia D Steen, MD | Georgetown University |
Study ID Numbers: | IRB 06-043 |
Study First Received: | September 14, 2006 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00377455 |
Health Authority: | United States: Institutional Review Board |
scleroderma systemic sclerosis bosentan pulmonary hypertension |
PHAROS PHROS exercise echocardiogram |
Skin Diseases Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Connective Tissue Diseases |
Vascular Diseases Sclerosis Scleroderma, Systemic Bosentan Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |