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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2011

Last Updated Date

January 27, 2011

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01270750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bosentan for Severe Mitral Valve Dysfunction

Official Title ^ICMJE

Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

SECONDARY PULMONARY HYPERTENSION
MITRAL STENOSIS
CHILDHOOD RHEUMATOID FEVER
CONGESTIVE HEART FAILURE

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

60 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: GEORGE VLACHOGIORGOS, MD PHD

00306936192419

georgevlacho@gmail.com

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT01270750

Other Study ID Numbers ^ICMJE

GHC2/29/22-09-2008

Has Data Monitoring Committee

Responsible Party

GEORGE VLACHOGIORGOS, General Hospital of Chalkida

Study Sponsor ^ICMJE

General Hospital of Chalkida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

GEORGE VLACHOGIORGOS, MD PHD

GENERAL HOSPITAL OF CHALKIDA, GREECE

Information Provided By

General Hospital of Chalkida

Verification Date

January 2011

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

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