Cardiac Sarcoidosis Response To Steroids Trial (CASTOR)

CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Sarcoidosis; Cardiac Sarcoidosis
• Intervention / Treatment: Drug: Prednisone

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Pablo B. Nery, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 27, 2010
• First Posted (Estimate): September 28, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Sarcoidosis; Cardiac Sarcoidosis
• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: UOHI-03