Primary Endpoints | Feasibility Endpoint | Number of subjects enrolled, stratified by race/ethnicity |
Efficacy Endpoints | Interval changes in inflammatory biomarkers (CRP and IL-6) after 4Â weeks of treatment with anakinra | |
Secondary Endpoints | Clinical Outcomes | Incidence of death (cardiac and non-cardiac) Hospitalization (for cardiac and non-cardiac reasons) Change in medication use for sarcoidosis (number and doses) Change in medication use for heart disease (number and doses) Adverse events at 28, 60, and 180Â days |
 | 24 Hour Holter | Number, duration, and rate of sustained VT Number, duration, and rate of non-sustained VT Absolute number and percentage of premature ventricular contractions Number and type of AV blocks Number and duration of sinus pauses Occurrence of atrial arrhythmias |
 | Quality of Life | Change in Sarcoidosis Assessment Tool scores |
[Imaging Substudy @ VCU] | Cardiac Magnetic Resonance | Change in left ventricular ejection fraction Change in late gadolinium enhancement |
 | Cardiac FDG-PET | Change in intensity of tracer uptake |