- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270750
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
- Name: GEORGE VLACHOGIORGOS, MD PHD
- Phone Number: 00306936192419
- Email: georgevlacho@gmail.com
Study Locations
-
-
Evoia
-
Chalkida, Evoia, Greece, 34100
- Recruiting
- General Hospital of Chalkida
-
Contact:
- GEORGE VLACHOGIORGOS, MD PHD
- Phone Number: 00306936192419
- Email: georgevlacho@gmail.com
-
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
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
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplastic Processes
- Heart Valve Diseases
- Heart Failure
- Hypertension
- Neoplasm Metastasis
- Hypertension, Pulmonary
- Mitral Valve Stenosis
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Endothelin Receptor Antagonists
- Bosentan
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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