Clinical Trials Directory

Trials / Unknown

UnknownNCT01270750

Bosentan for Severe Mitral Valve Dysfunction

Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
General Hospital of Chalkida · Other Government
Sex
All
Age
60 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGBOSENTANTWICE DAILY PERORAL BOSENTAN, 125 MG DAILY DIVIDED IN TWO DOSES DURING THE FIRST MONTH AND 250 MG DAILY DIVIDED IN TWO DOSES SUBSEQUENTLY.

Timeline

Start date
2010-12-01
Primary completion
2011-06-01
Completion
2011-06-01
First posted
2011-01-05
Last updated
2011-01-28

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT01270750. Inclusion in this directory is not an endorsement.