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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Rabin Medical Center. Recruitment status was Not yet recruiting

First Received on June 25, 2008. No Changes Posted

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00705588

Purpose

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.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Tadalafil Drug: Vardenafil	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Tadalafil Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Six minute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Level of pro-NT BNP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Echo-derived parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Cardiopulmonary exercise test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).	Drug: Tadalafil Orally, titrated to maximum 20mg od Other Name: Cialis
Experimental: 2 Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)	Drug: Vardenafil Orally, titrated to 10 mg bid Other Name: Levitra

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705588

Contacts

Contact: Mordechai R Kramer, MD

972-3-937-7221

kremerm@clalit.org.il

Locations

Israel
Pulmonary Institute, Rabin Medical Center	Not yet recruiting
Petach Tikva, Israel, 49100
Sub-Investigator: Benjamin D Fox, BM BCh MRCP

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator:

Mordechai R Kramer, MD

Rabin Medical Center

More Information

No publications provided

Responsible Party:	Prof MR Kramer, Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00705588 History of Changes
Other Study ID Numbers:	RMC084936CTIL
Study First Received:	June 25, 2008
Last Updated:	June 25, 2008
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Tadalafil
Vardenafil

Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012