Pulmonary Arterial Hypertension
Conditions
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 (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.
Interventions
DRUGTadalafil
Orally, titrated to maximum 20mg od
DRUGVardenafil
Orally, titrated to 10 mg bid
Sponsors
Rabin Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six minute walking distance | 12 weeks |
| Level of pro-NT BNP | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Echo-derived parameters | 12 weeks |
| Cardiopulmonary exercise test | 12 weeks |
Countries
Israel
Contacts
Primary ContactMordechai R Kramer, MD
Outcome results
None listed