Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
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: Levitra (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Rabin Medical Center Overall contact: Mordechai R Kramer, MD, Phone: 972-505710702, Email: kremerm@clalit.org.il
Summary
Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality
of life and inability to function, despite medical therapy Current consensus states that
combination therapy with different classes of PAH-specific therapy is likely to bring
additional benefit to PAH patients. In this study we plan to study how exercise performance
changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain
symptomatic from PAH when treated with inhaled iloprost.
Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is
tolerated by the patients, after a two week period, up titration to 20 mg bid will be
permitted, at the discretion of the investigators.
According to treatment protocol up titration will be done carefully and whenever side
effects will be reported up titration will be stopped or dosage will be decreased or stopped
according to the investigator judgment.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for
the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for
the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall
in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of
the investigator. BP will be measured according to the following protocol.
Pre-dose Immediately before administration of vardenafil. This will be timed approximately
one hour prior to the next planned dose of iloprost.
Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.
Post-inhalation Immediately following completion of iloprost inhalation and every fifteen
minutes for one hour.
Prior to discharge Two hours following the iloprost.
Later monitoring At all follow-up visits, BP will be measured.
This is an open-label study to evaluate the safety and efficacy of adding higher doses of
vardenafil to inhaled iloprost over 3 months.
Clinical Details
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in 6 minute walk or New York Heart Association functional class.
Secondary outcome: Changes in Pulmonary artery pressure assessed (by echo), exercise test parameters, pro-NT BNP, quality of life. Clinical worsening during study, study drop-out and adverse events during the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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 PAPā„25mmHg at rest by a PCWP<15mmHg and by PVR >3 Wood Units.
2. Currently stable for at least 3 months with inhaled iloprost, between 5-9 doses per
day, using the I-Neb device.
3. Willing and able to participate in all study follow-up procedures.
4. New York Heart Association (NYHA) Class II-IV.
5. Six minute walking distance between 100-450 meters at the baseline assessment.
6. Women of child-bearing age must demonstrate adequate contraception or undergo a
pregnancy test.
7. Patients with inoperable pulmonary thromboembolic disease or congenital heart disease
are eligible for inclusion.
Exclusion Criteria:
1. Functional Class NYHA Class I.
2. PAH due to left heart disease, chronic lung diseases (VC or FEV1 <60% of predicted),
chronic hypoxia or chronic thromboembolic disease.
3. Acute intercurrent illness requiring hospital admission in the month proceeding
screening.
4. Any non-PAH medical condition likely to interfere with participation in evaluation of
study endpoints, e. g. musculoskeletal disorders.
5. Any uncontrolled or terminal non-PAH medical condition likely to interfere with
completion of the study, according to the judgment of the study physician.
6. Concomitant therapy with drugs known to interact adversely with the study drug
(Nitrates, alpha-adrenergic receptor antagonists, CYP3A4 inhibitors (HIV protease
inhibitors, ketoconazole, itraconazole, erythromycin
7. Chronic renal failure - creatinine clearance< 50ml/min as calculated with the
Cockcroft equation.
8. Current participation in another clinical trial.
9. Pregnancy or planned pregnancy during the study period.
Locations and Contacts
Mordechai R Kramer, MD, Phone: 972-505710702, Email: kremerm@clalit.org.il
Pulmonary Institute,Rabin Medical Center, Petach Tikva 49100, Israel; Not yet recruiting Mordechai R Kramer, MD, Phone: 972-39377221, Email: kremerm@clalit.org.il Mordechai R Kramer, MD, Principal Investigator
Additional Information
Starting date: September 2012
Last updated: July 24, 2012
|