NCT01270750

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

January 4, 2011

Last Update Submit

January 27, 2011

Conditions

SECONDARY PULMONARY HYPERTENSIONMITRAL STENOSISCHILDHOOD RHEUMATOID FEVERCONGESTIVE HEART FAILURE

Keywords

ENDOTHELIN RECEPTOR ANTAGONISTBOSENTANSECONDARY PULMONARY HYPERTENSIONRHEUMATOID FEVERCONGESTIVE HEART FAILURESECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS

Outcome Measures

Primary Outcomes (2)

  • SIX MINUTE WALKING DISTANCE

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

    SIX MONTHS

  • MAXIMAL OXYGEN UPTAKE

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

    6 MONTHS

Secondary Outcomes (4)

  • ECHOCARDIOGRAPHIC PULMONARY PRESSURE

    6 MONTHS

  • ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION

    6 MONTHS

  • SERUM PRO-BNP

    6 MONTHS

  • DYSPNEA

    6 MONTHS

Interventions

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.

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Chalkida

Chalcis, Evoia, 34100, Greece

RECRUITING

MeSH Terms

Conditions

Mitral Valve StenosisHeart Failure

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GEORGE VLACHOGIORGOS, MD PHD

    GENERAL HOSPITAL OF CHALKIDA, GREECE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GEORGE VLACHOGIORGOS, MD PHD

CONTACT

00306936192419georgevlacho@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

GR(1)