Bosentan for Severe Mitral Valve Dysfunction

Phase 1

• Conditions: SECONDARY PULMONARY HYPERTENSION; MITRAL STENOSIS; CHILDHOOD RHEUMATOID FEVER; CONGESTIVE HEART FAILURE

• Registration Number: NCT01270750
• Lead Sponsor: General Hospital of Chalkida

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

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Outpatient
• > 60 Yrs Old
• < 85 Yrs Old
• Stable disease
• Congestive heart failure NYHA IIIB/V
• Inoperable mitral stenosis due to childhood rheumatoid fever
• Mean pulmonary artery pressure > 40 cm H2O

Exclusion Criteria

• Prior treatment with endothelin receptor antagonist(s)
• Hospitalization (exacerbation)
• Cardiac valve surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SIX MINUTE WALKING DISTANCE	SIX MONTHS	CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
MAXIMAL OXYGEN UPTAKE	6 MONTHS	CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.

Secondary Outcome Measures

Name	Time	Method
ECHOCARDIOGRAPHIC PULMONARY PRESSURE	6 MONTHS	ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION	6 MONTHS	ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
SERUM PRO-BNP	6 MONTHS	ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
DYSPNEA	6 MONTHS	CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.

Trial Locations

Locations (1)

General Hospital of Chalkida; 🇬🇷 Chalkida, Evoia, Greece