Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
- Registration Number
- NCT00851929
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
- Detailed Description
Primary Endpoint: Change in 6 minute walk distance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sarcoidosis associated pulmonary hypertension Ambrisentan sarcoidosis associated pulmonary hypertension
- Primary Outcome Measures
Name Time Method Change in 6 minute walk distance. 4 months of therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Medical Univerrsity of South Carolina
🇺🇸Charleston, South Carolina, United States