Bosentan for Severe Mitral Valve Dysfunction (BOSMIVAR)

January 27, 2011 updated by: General Hospital of Chalkida

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Evoia
      • Chalkida, Evoia, Greece, 34100
        • Recruiting
        • General Hospital of Chalkida
        • Contact:
        • Principal Investigator:
          • GEORGE VLACHOGIORGOS, MD PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SIX MINUTE WALKING DISTANCE
Time Frame: SIX MONTHS
CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
SIX MONTHS
MAXIMAL OXYGEN UPTAKE
Time Frame: 6 MONTHS
CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
6 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 MONTHS
ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION
Time Frame: 6 MONTHS
ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
6 MONTHS
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.
6 MONTHS
DYSPNEA
Time Frame: 6 MONTHS
CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chalkida

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Estimate)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHC2/29/22-09-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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