Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Gilead Sciences
• Treatments: Ambrisentan

Criteria

Inclusion Criteria:

• Biopsy proven sarcoidosis

• Mean pulmonary artery pressure > 25 mmHg at rest and greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study

• Pulmonary capillary wedge pressure ≤ 15 mmHg

• PVR values >3.0 Woods units

• Forced vital capacity (FVC) >40%

• WHO functional class II or III

• Stable sarcoidosis treatment regimen for three months prior to entry into study

• 6 minute walk distance between 150-450 meters

• Stable dose of antihypertensive medications

• On no other medication to treat PAH (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study

• Non-pregnant females

Exclusion Criteria:

• Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)

• Severe systemic hypertension > 170/95

• Patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction

• Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study

• Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, etc.)

• Use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).

• WHO functional class IV status

• Patients with significant left ventricular dysfunction

• Significant liver dysfunction not due to sarcoidosis.

• Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.