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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 distance

Level of pro-NT BNP

Secondary outcome:

Echo-derived parameters

Cardiopulmonary 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

Page last updated: August 23, 2015

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