Cardiac Sarcoidosis Response To Steroids Trial

Study Overview
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Brief Summary
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There are no published clinical consensus guidelines on the treatment of cardiac sarcoidosis. Corticosteroid therapy is advocated by some experts, but is based on small observational studies, with varied clinical response. Objectives of this trial: to systemically assess the response of patients with cardiac sarcoidosis, to treatment with corticosteroids to identify the clinical predictors of response to treatment with corticosteroids to assess the utility of imaging with PET and MRI to predict response to treatment with corticosteroids to determine the prevalence of cardiac sarcoidosis in young patients with unexplained heart block and in patients with unexplained dilated cardiomyopathy associated with ventricular tachycardia to use the data from this pilot study to assess the need, feasibility, and sample size for a larger multicentre trial

Official Title
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CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial

Conditions
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Cardiac Sarcoidosis, Sarcoidosis

Intervention / Treatment
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* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: evidence of clinical cardiac sarcoidosis causing significant conduction system disease (defined as complete right bundle branch block and left axis deviation or left bundle branch block or second or third degree AV block in young patients (< 60 yrs) AND/OR evidence of clinical cardiac sarcoidosis causing non-ischemic dilated cardiomyopathy and sustained ventricular tachycardia AND PET or MRI imaging supporting the diagnosis of cardiac sarcoidosis Exclusion Criteria: unable or unwilling to provide informed consent history of noncompliance of medical therapy patients with active infection patients with active inflammatory disease not related to sarcoidosis patients with other known causes of heart block or LV dysfunction patients with known active malignancy patients wwho are pregnant or lactating patients with other indications for steroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisone<br>Prednisone 0.5 mg/Kg per day orally for 3 months | Drug: Prednisone<br>* Prednisone 0.5 mg/Kg orally per day for 3 months<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets(s) taken orally per day | Drug: Prednisone<br>* Prednisone 0.5 mg/Kg orally per day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure hospitalization and sustained ventricular arrhythmia | Considered a responder to steroid therapy if alive, no heart failure hospitalization and no sustained ventricular arrhythmia, and improvement in one or both of: LV function (defined as 5% increase in EF units or 10% decrease in volumes) greater than or equal to one heart block grade (defined as improvement from eg. third to second degree AV block or resolution of bundle branch block) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity by PET imaging | Change in disease activity as assessed by PET imaging (comparing pre-treatment to 3 month scans) Atrial fibrillation burden during the 3 month treatment period (from pacemaker or ICD diagnostics) Ventricular arrhythmia burden during the 3 month treatment period Percent of ventricular pacing (pacemaker programming will be standardized in all patients) Patient Quality of life (using SF-36 questionnaire) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Sarcoidosis, Sarcoidosis