Status:
COMPLETED
Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
Lead Sponsor:
University of Cincinnati
Conditions:
Sarcoidosis
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.
Detailed Description
Pulmonary hypertension has been described in sarcoidosis. It can be a significant problem, not responsive to treatment with anti-inflammatory drugs for the sarcoidosis (1;2). Inhaled iloprost has been...
Eligibility Criteria
Inclusion
- Patients with known sarcoidosis 17
- Age 18 or greater
- Patients with documented pulmonary hypertension with a PA mean \> 25 mm as measured by cardiac catheterization within six months of entry into the study
- Patients with dyspnea
- Six minute walk distance of between 100 to 500 meters
- Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
- Patients able to provide written consent
Exclusion
- Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in the prior 28 days (patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker)
- Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
- Patients with World Health Organization (WHO) class IV status
- Patients who are pregnant or breast feeding
- Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
- Significant liver dysfunction not due to sarcoidosis
- Patients with severe other organ disease felt by investigators to impact survival during the course of the study
- Patients unable to perform the 6 inhalation treatments required for therapy
- Patients with \< 90 mm Hg Systolic systemic blood pressure will be excluded
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00403650
Start Date
November 1 2006
End Date
September 1 2008
Last Update
April 12 2013
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267