CHILDHOOD RHEUMATOID FEVER, CONGESTIVE HEART FAILURE, MITRAL STENOSIS, SECONDARY PULMONARY HYPERTENSION
Conditions
Keywords
ENDOTHELIN RECEPTOR ANTAGONIST, BOSENTAN, SECONDARY PULMONARY HYPERTENSION, RHEUMATOID FEVER, CONGESTIVE HEART FAILURE, SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS
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.
Interventions
DRUGBOSENTAN
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
General Hospital of Chalkida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SIX MINUTE WALKING DISTANCE | SIX MONTHS | CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE. |
| MAXIMAL OXYGEN UPTAKE | 6 MONTHS | CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECHOCARDIOGRAPHIC PULMONARY PRESSURE | 6 MONTHS | ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES. |
| ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION | 6 MONTHS | ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES. |
| SERUM PRO-BNP | 6 MONTHS | ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES. |
| DYSPNEA | 6 MONTHS | CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES. |
Countries
Greece
Contacts
Primary ContactGEORGE VLACHOGIORGOS, MD PHD
Outcome results
None listed