Pulmonary Arterial Hypertension | Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Pulmonary Arterial Hypertension research study
What is the primary objective of this study?
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 (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil). Although these drugs are known to be effective alone, little is known about combining them together in various combinations. In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Pulmonary Arterial Hypertension
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:TadalafilOrally, titrated to maximum 20mg od
Drug:VardenafilOrally, titrated to 10 mg bid
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
2Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
Start Date: August 2008
Phase: Phase 4
Primary Outcome: Six minute walking distance
Secondary Outcome: Echo-derived parameters
Study sponsors, principal investigator, and references
Principal Investigator: Mordechai R Kramer, MD
Lead Sponsor: Rabin Medical Center