Bosentan for Severe Mitral Valve Dysfunction

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

SIX MINUTE WALKING DISTANCE

Secondary Outcome

 ECHOCARDIOGRAPHIC PULMONARY PRESSURE

Condition

SECONDARY PULMONARY HYPERTENSION

Intervention

BOSENTAN


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

          -  < 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
      

Gender

All

Ages

60 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

GEORGE VLACHOGIORGOS, MD PHD, 00306936192419, [email protected]

Location Countries

Greece

Location Countries

Greece

Administrative Informations


NCT ID

NCT01270750

Organization ID

GHC2/29/22-09-2008



Study Sponsor

General Hospital of Chalkida


Study Sponsor

GEORGE VLACHOGIORGOS, MD PHD, Principal Investigator, GENERAL HOSPITAL OF CHALKIDA, GREECE


Verification Date

January 2011