Bosentan for Severe Mitral Valve Dysfunction
Information source: General Hospital of Chalkida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: SECONDARY PULMONARY HYPERTENSION; MITRAL STENOSIS; CHILDHOOD RHEUMATOID FEVER; CONGESTIVE HEART FAILURE
Intervention: BOSENTAN (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: General Hospital of Chalkida Official(s) and/or principal investigator(s): GEORGE VLACHOGIORGOS, MD PHD, Principal Investigator, Affiliation: GENERAL HOSPITAL OF CHALKIDA, GREECE
Overall contact: GEORGE VLACHOGIORGOS, MD PHD, Phone: 00306936192419, Email: georgevlacho@gmail.com
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.
Clinical Details
Official title: Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: SIX MINUTE WALKING DISTANCEMAXIMAL OXYGEN UPTAKE
Secondary outcome: ECHOCARDIOGRAPHIC PULMONARY PRESSUREECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION SERUM PRO-BNP DYSPNEA
Eligibility
Minimum age: 60 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
GEORGE VLACHOGIORGOS, MD PHD, Phone: 00306936192419, Email: georgevlacho@gmail.com
General Hospital of Chalkida, Chalkida, Evoia 34100, Greece; Recruiting GEORGE VLACHOGIORGOS, MD PHD, Phone: 00306936192419, Email: georgevlacho@gmail.com GEORGE VLACHOGIORGOS, MD PHD, Principal Investigator
Additional Information
Starting date: December 2010
Last updated: January 27, 2011
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