Skip to main content

Table 3 The primary endpoints, including the feasibility endpoint and efficacy endpoints, and secondary endpoints for the MAGiC-ART trial are shown

From: Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)

Primary Endpoints Feasibility Endpoint Number of subjects enrolled, stratified by race/ethnicity
Efficacy Endpoints Interval changes in inflammatory biomarkers (CRP and IL-6) after 4 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 180 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