Cardiac Sarcoidosis Response To Steroids Trial (CASTOR)

University of Ottawa Heart Institute

Status and phase: Withdrawn; Phase 4

Conditions: Sarcoidosis; Cardiac Sarcoidosis

Treatments: Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01210677

UOHI-03

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Prednisone

Active Comparator group

Description:

Prednisone 0.5 mg/Kg per day orally for 3 months

Treatment:

Drug: Prednisone

Placebo

Placebo Comparator group

Description:

Matching placebo tablets(s) taken orally per day

Treatment:

Drug: Prednisone