Bosentan for Severe Mitral Valve Dysfunction (BOSMIVAR)
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ClinicalTrials.gov Identifier: NCT01270750
Recruitment Status : Unknown
Verified January 2011 by General Hospital of Chalkida. Recruitment status was: Recruiting
Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary arterial hypertension, but has also been documented in secondary pulmonary hypertension due to congestive heart failure, including cardiac valve disease. The investigators aim to examine the clinical and physiologic effects of bosentan therapy in patients with secondary pulmonary hypertension due to severe, inoperable cardiac valve disease, using a single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be exercise capacity at six months determined by six-minute walking distance and cardiopulmonary exercise testing. Secondary end-points will be symptomatic relief, echocardiographic left ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse events at six months.
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Ages Eligible for Study:
60 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
> 60 Yrs Old
< 85 Yrs Old
Congestive heart failure NYHA IIIB/V
Inoperable mitral stenosis due to childhood rheumatoid fever
Mean pulmonary artery pressure > 40 cm H2O
Prior treatment with endothelin receptor antagonist(s)