Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Iloprost

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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