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
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00705588
First received: June 25, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014