View Clinical Trial (Medical Research Study)

Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension - NCT00851929-(Clinical Trial 274749)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Chapel Hill
State:  
NC
Zip Code:
Conditions: Sarcoidosis - Pulmonary Hypertension
Purpose: Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Study summary: Primary Endpoint: Change in 6 minute walk distance. Secondary Endpoints: - Safety - Oxygen saturation at rest and with exercise - Hospitalization - Mortality - WHO functional class - Quality of life as measured by - Short-form 36 - Sarcoidosis Health Questionnaire - Dyspnea as measured by - Borg Dyspnea Index - St. George Respiratory Questionnaire - Sarcoidosis activity as measured by the - STAI sarcoidosis instrument (33) - Prednisone dose - Pulmonary function - Forced vital capacity (FVC) - Diffusion (DLCO) - Endothelin-1 levels - Bronchoalveolar lavage - Plasma - B-type natruetic peptide - Inflammatory and fibrotic mediators (IL-2, IL-6, IL-12, IL-18, IL-23, TNF-α) in BALF - Compliance with treatment - Time to clinical worsening (defined by the initiation of ambrisentan treatment to the first occurrence of death, lung transplantation, hospitalization for pulmonary arterial hypertension, arterial septostomy, a change in chronic prostanoid or sildenafil treatment due to protocol defined worsening criteria or study withdrawal due to additional of other clinically approved PAH therapeutic agents)
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.
Study is available at: University of North Carolina Medical Center
Chapel Hill, NC
United States

Primary Contact:
James Ford, MD
Email: hford@unch.unc.edu

Secondary Contact:
Marc A Judson, MD
Email: judsonma@musc.edu
Phone: 843-697-7272
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.