Back to resultsLong Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Primary Purpose
Pulmonary Arterial Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Tadalafil
Vardenafil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
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.
Sites / Locations
- Pulmonary Institute, Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
Outcomes
Primary Outcome Measures
Six minute walking distance
Level of pro-NT BNP
Secondary Outcome Measures
Echo-derived parameters
Cardiopulmonary exercise test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00705588
Brief Title
Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
Arm Title
2
Arm Type
Experimental
Arm Description
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Other Intervention Name(s)
Cialis
Intervention Description
Orally, titrated to maximum 20mg od
Intervention Type
Drug
Intervention Name(s)
Vardenafil
Other Intervention Name(s)
Levitra
Intervention Description
Orally, titrated to 10 mg bid
Primary Outcome Measure Information:
Title
Six minute walking distance
Time Frame
12 weeks
Title
Level of pro-NT BNP
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Echo-derived parameters
Time Frame
12 weeks
Title
Cardiopulmonary exercise test
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mordechai R Kramer, MD
Phone
972-3-937-7221
Email
kremerm@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Institute, Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin D Fox, BM BCh MRCP
12. IPD Sharing Statement
Learn more about this trial
Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
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