Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib
The investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- Measuring circulating markers of Nilotinib affect [ Time Frame: within one year of the end of the study ] [ Designated as safety issue: No ]We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib.
- Evaluate effect of Nilotinib on the activation of mast cells. [ Time Frame: within one year of the end of the study ] [ Designated as safety issue: No ]We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib. We will also look at the proliferation of mast cell progenitors and correlate this to clinical markers used to monitor this disease.
|Study Start Date:||August 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Subjects with PAH treated with nilotinib|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320865
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Kewal Asosingh, Ph.D||The Cleveland Clinic|