Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

University of Cincinnati

Status and phase

Completed

Phase 4

Conditions

Sarcoidosis

Pulmonary Arterial Hypertension

Treatments

Drug: Iloprost

Study type

Interventional

Funder types

Other

Identifiers

NCT00403650

Sarcoid 6

Details and patient eligibility

About

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

Full 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 approved for treatment of pulmonary hypertension (3). We propose to study the effectiveness of inhaled iloprost for sarcoidosis associated pulmonary hypertension (SAPAH). This is an open label trial, with patients receiving 16 weeks of therapy. Clinical and hemodynamic outcome of therapy will be assessed.

Enrollment

20 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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