Bosentan for Severe Mitral Valve Dysfunction — BOSMIVAR  

CONGESTIVE HEART FAILURE Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CHILDHOOD RHEUMATOID FEVER
• CONGESTIVE HEART FAILURE
• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• MITRAL STENOSIS
• Mitral Valve Stenosis
• Neoplasm Metastasis
• SECONDARY PULMONARY HYPERTENSION

• NCT number: NCT01270750
• Study type: Interventional
• Source: General Hospital of Chalkida
• Contact: GEORGE VLACHOGIORGOS, MD PHD
• Phone: 00306936192419
• Email: georgevlacho@gmail.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2010
• Completion date: June 2011