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

Pulmonary Arterial Hypertension Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00705588
• Other study ID #: RMC084936CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 25, 2008
• Last updated: June 25, 2008
• Start date: August 2008

Study information

• Verified date: May 2008
• Source: Rabin Medical Center
• Contact: Mordechai R Kramer, MD
• Phone: 972-3-937-7221
• Email: kremerm[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Tadalafil
Orally, titrated to maximum 20mg od
• Vardenafil
Orally, titrated to 10 mg bid

Locations

Country	Name	City	State
Israel	Pulmonary Institute, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minute walking distance		12 weeks	No
Primary	Level of pro-NT BNP		12 weeks	No
Secondary	Echo-derived parameters		12 weeks	No
Secondary	Cardiopulmonary exercise test		12 weeks	No