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Bosentan for Severe Mitral Valve Dysfunction

Descriptive Information
Brief Title † Bosentan for Severe Mitral Valve Dysfunction
Official Title † Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction
Brief 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.
Detailed Description
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † SIX MINUTE WALKING DISTANCE
Secondary Outcome Measure † ECHOCARDIOGRAPHIC PULMONARY PRESSURE
Condition † SECONDARY PULMONARY HYPERTENSION MITRAL STENOSIS CHILDHOOD RHEUMATOID FEVER CONGESTIVE HEART FAILURE
Intervention † DrugBOSENTAN
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 10
Start Date † December 2010
Completion Date June 2011
Primary Completion Date June 2011
Eligibility Criteria † Inclusion Criteria: - Outpatient - > 60 Yrs Old - 40 cm H2O Exclusion Criteria: - Prior treatment with endothelin receptor antagonist(s) - Hospitalization (exacerbation) - Cardiac valve surgery
Gender Both
Ages 60 Years - 85 Years
Accepts Healthy Volunteers No
Contacts †† GEORGE VLACHOGIORGOS, MD PHD, 00306936192419, georgevlacho@gmail.com
Location Countries † Greece
Administrative Information
NCT ID † NCT01270750
Organization ID GHC2/29/22-09-2008
Secondary IDs ††
Responsible Party
Study Sponsor † General Hospital of Chalkida
Collaborators ††
Investigators † Principal Investigator: GEORGE VLACHOGIORGOS, MD PHD, GENERAL HOSPITAL OF CHALKIDA, GREECE
Information Provided By
Verification Date January 2011
First Received Date † January 4, 2011
Last Updated Date January 27, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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