Sarcoidosis | Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Sarcoidosis research study
What is the primary objective of this study?
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Ambrisentanambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
sarcoidosis associated pulmonary hypertensionsarcoidosis associated pulmonary hypertension
Start Date: November 2008
Completed Date: November 2011
Phase: Phase 2/Phase 3
Primary Outcome: Change in 6 minute walk distance.
Study sponsors, principal investigator, and references
Principal Investigator: Marc A Judson, MD
Lead Sponsor: Medical University of South Carolina
Collaborator: Gilead Sciences