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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