A Multi-Center Observational Study Assessing the Utility of an Immune Cell Function Assay in a Cardiac Sarcoid Population

Brief description of study

Sarcoid is an autoimmune disease that can be found in any and every organ system. The greatest degree of morbidity and mortality comes from cardiac involvement where it can lead to sudden cardiac death, heart block, and heart failure. The basics of the treatment for cardiac sarcoid include appropriate preventative treatment for ventricular arrhythmias, guideline directed medical treatment for heart failure, and immunosuppression to decrease active cardiac inflammation. The amount of immunosuppression and with which medication is of expert opinion. Using PET scan, we can help assess for successful suppression of the disease, but often 2nd or 3rd line treatments are required after initial therapy strategy is deemed insufficient. As of now, there are no predictors of who will fail initial treatment. For this study, there are three different hypotheses. First, we suspect the baseline Immuknow tertile (low, medium, high) will correlate with the rate of response to first line immunosuppression with low being more likely than the combined medium/high grouping to be responsive on first clinically indicated PET follow up. Second, that a subsequent decrease in ImmuKnow grade, for those that start in the medium or high range, will be predictive of resolution of inflammation on cardiac PET. Lastly, we would like to assess whether an intermediate ImmuKnow assay, drawn at 1 month, would be predictive of response at 3 month follow up. The study population will include adults with a clinical or histological diagnosis of cardiac sarcoidosis found to have active inflammation on cardiac PET scan who are not currently on immunosuppressive therapy. This should be their first time undergoing treatment for cardiac sarcoid (i.e. not with disease recurrence). This will give us a uniform patient population that will not have effects of prior immunosuppression as to their response to current treatment, and not possibly already have treatment failure. We will also be storing biologic samples for future analysis. We believe that a change in the immunophenotype of an individual in response to treatment will be the hallmark of successful immunosuppression. We will be using these samples to assess this in the future.


Clinical Study Identifier: s21-00266
Principal Investigator: Randal Ian Goldberg.


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