Status:
UNKNOWN
Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Lead Sponsor:
Rabin Medical Center
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (...
Eligibility Criteria
Inclusion
- All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP \>25mmHg at rest or \>30mmHg with exercise, by a PCWP\< 15mmHg and by PVR \>3 Wood Units.
- Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
- Willing and able to participate in all study follow-up procedures.
- New York Heart Association (NYHA) Class II-IV.
- Six minute walking distance between 100-450 meters at the baseline assessment.
- Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
- Patients with congenital heart disease are eligible for inclusion.
Exclusion
- Functional Class NYHA Class I.
- PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 \< 60% of predicted) or chronic hypoxia.
- Acute intercurrent illness requiring hospital admission in the month proceeding screening.
- Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
- Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
- Concomitant therapy with drugs known to interact adversely with the study drug.
- Chronic renal failure - creatinine clearance \<50ml/min as calculated with the Cockcroft equation.
- Current participation in another clinical trial.
- Pregnancy or planned pregnancy during the study period.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00705588
Start Date
August 1 2008
Last Update
June 26 2008
Active Locations (1)
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1
Pulmonary Institute, Rabin Medical Center
Petah Tikva, Israel, 49100