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Bosentan for Severe Mitral Valve Dysfunction

NCT01270750 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-01-28

No results posted yet for this study

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.

Conditions

  • SECONDARY PULMONARY HYPERTENSION
  • MITRAL STENOSIS
  • CHILDHOOD RHEUMATOID FEVER
  • CONGESTIVE HEART FAILURE

Interventions

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.

Sponsors & Collaborators

  • General Hospital of Chalkida

    lead OTHER_GOV

Principal Investigators

  • GEORGE VLACHOGIORGOS, MD PHD · GENERAL HOSPITAL OF CHALKIDA, GREECE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Greece

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01270750 on ClinicalTrials.gov