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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GEORGE VLACHOGIORGOS, General Hospital of Chalkida
ClinicalTrials.gov Identifier: NCT01270750     History of Changes
Other Study ID Numbers: GHC2/29/22-09-2008
Study First Received: January 4, 2011
Last Updated: January 27, 2011
Health Authority: GREECE: HELLENIC NATIONAL HEALTH SYSTEM

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:
Constriction, Pathologic
Fever
Heart Failure
Hypertension
Hypertension, Pulmonary
Mitral Valve Stenosis
Pathological Conditions, Anatomical
Body Temperature Changes
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Valve Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014