Bosentan for Severe Mitral Valve Dysfunction

CONGESTIVE HEART FAILURE Clinical Trial

— BOSMIVAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01270750
• Other study ID #: GHC2/29/22-09-2008
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 4, 2011
• Last updated: January 27, 2011
• Start date: December 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2011
• Source: General Hospital of Chalkida
• Contact: GEORGE VLACHOGIORGOS, MD PHD
• Phone: 00306936192419
• Email: georgevlacho[@]gmail.com
• Is FDA regulated: No
• Health authority: GREECE: HELLENIC NATIONAL HEALTH SYSTEM
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

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

Intervention

Drug:
• BOSENTAN
TWICE DAILY PERORAL BOSENTAN, 125 MG DAILY DIVIDED IN TWO DOSES DURING THE FIRST MONTH AND 250 MG DAILY DIVIDED IN TWO DOSES SUBSEQUENTLY.

Locations

Country	Name	City	State
Greece	General Hospital of Chalkida	Chalkida	Evoia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chalkida

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIX MINUTE WALKING DISTANCE	CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.	SIX MONTHS	No
Primary	MAXIMAL OXYGEN UPTAKE	CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.	6 MONTHS	No
Secondary	ECHOCARDIOGRAPHIC PULMONARY PRESSURE	ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.	6 MONTHS	No
Secondary	ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION	ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.	6 MONTHS	No
Secondary	SERUM PRO-BNP	ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.	6 MONTHS	No
Secondary	DYSPNEA	CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.	6 MONTHS	No