Pulmonary Hypertension Clinical Trial
Official title:
A Prospective Randomized, Double Blind, Placebo-controlled, Safety and Efficacy Study of Bosentan as add-on Therapy in Progressive Pulmonary Sarcoidosis
Progressive pulmonary sarcoidosis occurs in up to twenty percent of patients who require
persistent treatment, but available treatment options have shown considerable long-term
toxicity and uncertain or unproven efficacy. In these patients, pulmonary fibrosis and
pulmonary hypertension are common complications which have major prognostic impact.
Endothelin-1 (ET-1) has been demonstrated to play a key role in pulmonary fibrosis and
pulmonary hypertension, and a potential role in pulmonary sarcoidosis. ET-1 is a potent
vasoconstrictor and can promote fibrosis, cell proliferation, and remodeling, and is
pro-inflammatory. Preliminary data have shown the therapeutic potential of the endothelin
receptor antagonist (ERA) bosentan in sarcoidosis associated pulmonary hypertension.
In this light, the therapeutic potential of bosentan as an add-on treatment in progressive
pulmonary sarcoidosis needs to be evaluated.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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