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Bosentan for Severe Mitral Valve Dysfunction (BOSMIVAR)

Primary Purpose

SECONDARY PULMONARY HYPERTENSION, MITRAL STENOSIS, CHILDHOOD RHEUMATOID FEVER

Status
Unknown status
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
BOSENTAN
Sponsored by
General Hospital of Chalkida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for SECONDARY PULMONARY HYPERTENSION focused on measuring ENDOTHELIN RECEPTOR ANTAGONIST, BOSENTAN, SECONDARY PULMONARY HYPERTENSION, RHEUMATOID FEVER, CONGESTIVE HEART FAILURE, SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of ChalkidaRecruiting

Outcomes

Primary Outcome Measures

SIX MINUTE WALKING DISTANCE
CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
MAXIMAL OXYGEN UPTAKE
CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.

Secondary Outcome Measures

ECHOCARDIOGRAPHIC PULMONARY PRESSURE
ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION
ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
SERUM PRO-BNP
ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
DYSPNEA
CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.

Full Information

First Posted
January 4, 2011
Last Updated
January 27, 2011
Sponsor
General Hospital of Chalkida
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1. Study Identification

Unique Protocol Identification Number
NCT01270750
Brief Title
Bosentan for Severe Mitral Valve Dysfunction
Acronym
BOSMIVAR
Official Title
Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
General Hospital of Chalkida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SECONDARY PULMONARY HYPERTENSION, MITRAL STENOSIS, CHILDHOOD RHEUMATOID FEVER, CONGESTIVE HEART FAILURE
Keywords
ENDOTHELIN RECEPTOR ANTAGONIST, BOSENTAN, SECONDARY PULMONARY HYPERTENSION, RHEUMATOID FEVER, CONGESTIVE HEART FAILURE, SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BOSENTAN
Intervention Description
TWICE DAILY PERORAL BOSENTAN, 125 MG DAILY DIVIDED IN TWO DOSES DURING THE FIRST MONTH AND 250 MG DAILY DIVIDED IN TWO DOSES SUBSEQUENTLY.
Primary Outcome Measure Information:
Title
SIX MINUTE WALKING DISTANCE
Description
CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
Time Frame
SIX MONTHS
Title
MAXIMAL OXYGEN UPTAKE
Description
CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
ECHOCARDIOGRAPHIC PULMONARY PRESSURE
Description
ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
Time Frame
6 MONTHS
Title
ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION
Description
ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
Time Frame
6 MONTHS
Title
SERUM PRO-BNP
Description
ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.
Time Frame
6 MONTHS
Title
DYSPNEA
Description
CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.
Time Frame
6 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GEORGE VLACHOGIORGOS, MD PHD
Phone
00306936192419
Email
georgevlacho@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GEORGE VLACHOGIORGOS, MD PHD
Organizational Affiliation
GENERAL HOSPITAL OF CHALKIDA, GREECE
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Chalkida
City
Chalkida
State/Province
Evoia
ZIP/Postal Code
34100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GEORGE VLACHOGIORGOS, MD PHD
Phone
00306936192419
Email
georgevlacho@gmail.com
First Name & Middle Initial & Last Name & Degree
GEORGE VLACHOGIORGOS, MD PHD

12. IPD Sharing Statement

Learn more about this trial

Bosentan for Severe Mitral Valve Dysfunction

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