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SECONDARY PULMONARY HYPERTENSIONPhase 1/2BOSMIVARNCT01270750

Bosentan for Severe Mitral Valve Dysfunction

A Phase 1/2 study testing BOSENTAN in people with SECONDARY PULMONARY HYPERTENSION and MITRAL STENOSIS, run by General Hospital of Chalkida at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
What is being tested?
BOSENTAN
How many people
10 participants
Where
1 siteGreece
Study dates
Dec 2010to Jun 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Prior treatment with endothelin receptor antagonist(s)
  • Hospitalization (exacerbation)
  • Cardiac valve surgery

Trial locations and contacts

1 site in 1 country.

GEORGE VLACHOGIORGOS, MD PHD contact

00306936192419

georgevlacho@gmail.com

Greece1 site, 1 recruiting

  • General Hospital of Chalkida

    Chalcis, Evoia, 34100

    GEORGE VLACHOGIORGOS, MD PHD, 00306936192419, georgevlacho@gmail.com

    GEORGE VLACHOGIORGOS, MD PHD

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Being tested
BOSENTAN
Keywords
ENDOTHELIN RECEPTOR ANTAGONIST, BOSENTAN, SECONDARY PULMONARY HYPERTENSION, RHEUMATOID FEVER, CONGESTIVE HEART FAILURE, SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS
Medical subject headings
Mitral Valve Stenosis, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOSENTANDrug

    TWICE DAILY PERORAL BOSENTAN, 125 MG DAILY DIVIDED IN TWO DOSES DURING THE FIRST MONTH AND 250 MG DAILY DIVIDED IN TWO DOSES SUBSEQUENTLY.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SIX MINUTE WALKING DISTANCE

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

    Measured: SIX MONTHS

  2. MAXIMAL OXYGEN UPTAKE

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

    Measured: 6 MONTHS

Secondary outcomes (4)

  1. ECHOCARDIOGRAPHIC PULMONARY PRESSURE

    ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.

    Measured: 6 MONTHS

  2. ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION

    ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.

    Measured: 6 MONTHS

  3. SERUM PRO-BNP

    ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.

    Measured: 6 MONTHS

  4. DYSPNEA

    CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.

    Measured: 6 MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionJun 2011 (estimated)
  4. Study completionJun 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01270750
Sponsor's protocol ID
GHC2/29/22-09-2008
Acronym
BOSMIVAR
Status last verified
Jan 2011
First submitted
4 Jan 2011
Last updated
28 Jan 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BOSENTAN in people with SECONDARY PULMONARY HYPERTENSION and MITRAL STENOSIS, run by General Hospital of Chalkida at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact GEORGE VLACHOGIORGOS, MD PHD (00306936192419, georgevlacho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SIX MINUTE WALKING DISTANCE (time frame: SIX MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01270750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.

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