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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 DISTANCE

MAXIMAL OXYGEN UPTAKE

Secondary outcome:

ECHOCARDIOGRAPHIC PULMONARY PRESSURE

ECHOCARDIOGRAPHIC 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

Page last updated: August 23, 2015

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