Bosentan for Severe Mitral Valve Dysfunction (BOSMIVAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by General Hospital of Chalkida.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
General Hospital of Chalkida
ClinicalTrials.gov Identifier:
NCT01270750
First received: January 4, 2011
Last updated: January 27, 2011
Last verified: January 2011

January 4, 2011
January 27, 2011
December 2010
June 2011   (final data collection date for primary outcome measure)
  • SIX MINUTE WALKING DISTANCE [ Time Frame: SIX MONTHS ] [ Designated as safety issue: No ]
    CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
  • MAXIMAL OXYGEN UPTAKE [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
Same as current
Complete list of historical versions of study NCT01270750 on ClinicalTrials.gov Archive Site
  • ECHOCARDIOGRAPHIC PULMONARY PRESSURE [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
  • ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
  • SERUM PRO-BNP [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
  • DYSPNEA [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.
Same as current
Not Provided
Not Provided
 
Bosentan for Severe Mitral Valve Dysfunction
Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • SECONDARY PULMONARY HYPERTENSION
  • MITRAL STENOSIS
  • CHILDHOOD RHEUMATOID FEVER
  • CONGESTIVE HEART FAILURE
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
60 Years to 85 Years
No
Contact: GEORGE VLACHOGIORGOS, MD PHD 00306936192419 georgevlacho@gmail.com
Greece
 
NCT01270750
GHC2/29/22-09-2008
No
GEORGE VLACHOGIORGOS, General Hospital of Chalkida
General Hospital of Chalkida
Not Provided
Principal Investigator: GEORGE VLACHOGIORGOS, MD PHD GENERAL HOSPITAL OF CHALKIDA, GREECE
General Hospital of Chalkida
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP