Clinical trial NCT00705588: Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Six minute walking distance
timeFrame: 12 weeks
measure: Level of pro-NT BNP
timeFrame: 12 weeks
Secondary outcomes:
measure: Echo-derived parameters
timeFrame: 12 weeks
measure: Cardiopulmonary exercise test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Mordechai R Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References: