Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

NCT ID: NCT00705588

Last Updated: 2008-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Orally, titrated to maximum 20mg od

2

Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)

Group Type: EXPERIMENTAL

Vardenafil

Intervention Type: DRUG

Orally, titrated to 10 mg bid

Interventions

Tadalafil

Orally, titrated to maximum 20mg od

Intervention Type: DRUG

Vardenafil

Orally, titrated to 10 mg bid

Intervention Type: DRUG

Other Intervention Names

Cialis; Levitra

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rabin Medical Center

Principal Investigators

Mordechai R Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Pulmonary Institute, Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Central Contacts

Mordechai R Kramer, MD

Role: CONTACT

Phone: 972-3-937-7221

Email: kremerm@clalit.org.il

Other Identifiers

RMC084936CTIL

Identifier Type: -

Identifier Source: org_study_id