Status:
COMPLETED
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Gilead Sciences
Conditions:
Sarcoidosis
Pulmonary Hypertension
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00851929
Start Date
November 1 2008
End Date
November 1 2011
Last Update
August 2 2018
Active Locations (2)
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1
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
2
Medical Univerrsity of South Carolina
Charleston, South Carolina, United States, 29466