Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: Tadalafil (Drug); Vardenafil (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Rabin Medical Center Official(s) and/or principal investigator(s): Mordechai R Kramer, MD, Principal Investigator, Affiliation: Rabin Medical Center
Overall contact: Mordechai R Kramer, MD, Phone: 972-3-937-7221, Email: kremerm@clalit.org.il
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.
Clinical Details
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Six minute walking distanceLevel of pro-NT BNP
Secondary outcome: Echo-derived parametersCardiopulmonary exercise test
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mordechai R Kramer, MD, Phone: 972-3-937-7221, Email: kremerm@clalit.org.il
Pulmonary Institute, Rabin Medical Center, Petach Tikva 49100, Israel; Not yet recruiting Benjamin D Fox, BM BCh MRCP, Sub-Investigator
Additional Information
Starting date: August 2008
Last updated: June 25, 2008
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