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Bosentan for Severe Mitral Valve Dysfunction (BOSMIVAR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by General Hospital of Chalkida.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270750
First Posted: January 5, 2011
Last Update Posted: January 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
General Hospital of Chalkida
  Purpose
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.

Condition Intervention Phase
SECONDARY PULMONARY HYPERTENSION MITRAL STENOSIS CHILDHOOD RHEUMATOID FEVER CONGESTIVE HEART FAILURE Drug: BOSENTAN Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction

Resource links provided by NLM:


Further study details as provided by General Hospital of Chalkida:

Primary Outcome Measures:
  • SIX MINUTE WALKING DISTANCE [ Time Frame: SIX MONTHS ]
    CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.

  • MAXIMAL OXYGEN UPTAKE [ Time Frame: 6 MONTHS ]
    CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.


Secondary Outcome Measures:
  • ECHOCARDIOGRAPHIC PULMONARY PRESSURE [ Time Frame: 6 MONTHS ]
    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 ]
    ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.

  • SERUM PRO-BNP [ Time Frame: 6 MONTHS ]
    ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.

  • DYSPNEA [ Time Frame: 6 MONTHS ]
    CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.


Estimated Enrollment: 10
Study Start Date: December 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270750


Contacts
Contact: GEORGE VLACHOGIORGOS, MD PHD 00306936192419 georgevlacho@gmail.com

Locations
Greece
General Hospital of Chalkida Recruiting
Chalkida, Evoia, Greece, 34100
Contact: GEORGE VLACHOGIORGOS, MD PHD    00306936192419    georgevlacho@gmail.com   
Principal Investigator: GEORGE VLACHOGIORGOS, MD PHD         
Sponsors and Collaborators
General Hospital of Chalkida
Investigators
Principal Investigator: GEORGE VLACHOGIORGOS, MD PHD GENERAL HOSPITAL OF CHALKIDA, GREECE
  More Information

Responsible Party: GEORGE VLACHOGIORGOS, General Hospital of Chalkida
ClinicalTrials.gov Identifier: NCT01270750     History of Changes
Other Study ID Numbers: GHC2/29/22-09-2008
First Submitted: January 4, 2011
First Posted: January 5, 2011
Last Update Posted: January 28, 2011
Last Verified: January 2011

Keywords provided by General Hospital of Chalkida:
ENDOTHELIN RECEPTOR ANTAGONIST
BOSENTAN
SECONDARY PULMONARY HYPERTENSION
RHEUMATOID FEVER
CONGESTIVE HEART FAILURE
SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS

Additional relevant MeSH terms:
Hypertension
Heart Failure
Neoplasm Metastasis
Hypertension, Pulmonary
Mitral Valve Stenosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Heart Valve Diseases
Bosentan
Endothelin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action