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Cardiac Sarcoidosis Response To Steroids Trial (CASTOR)

Primary Purpose

Cardiac Sarcoidosis, Sarcoidosis

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Prednisone
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Sarcoidosis focused on measuring Cardiac Sarcoidosis, Sarcoidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prednisone

Placebo

Arm Description

Prednisone 0.5 mg/Kg per day orally for 3 months

Matching placebo tablets(s) taken orally per day

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
September 27, 2010
Last Updated
October 29, 2013
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01210677
Brief Title
Cardiac Sarcoidosis Response To Steroids Trial
Acronym
CASTOR
Official Title
CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No funding obtained.
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Sarcoidosis, Sarcoidosis
Keywords
Cardiac Sarcoidosis, Sarcoidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Prednisone 0.5 mg/Kg per day orally for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets(s) taken orally per day
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 0.5 mg/Kg orally per day for 3 months
Primary Outcome Measure Information:
Title
Heart failure hospitalization and sustained ventricular arrhythmia
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in disease activity by PET imaging
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Birnie, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo B. Nery, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

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Cardiac Sarcoidosis Response To Steroids Trial

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