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Cardiac Sarcoidosis Response To Steroids Trial (CASTOR)

This study has been withdrawn prior to enrollment.
(No funding obtained.)
Sponsor:
Information provided by (Responsible Party):
David Birnie, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01210677
First received: September 27, 2010
Last updated: October 29, 2013
Last verified: October 2013

September 27, 2010
October 29, 2013
April 2014
April 2016   (final data collection date for primary outcome measure)
Heart failure hospitalization and sustained ventricular arrhythmia [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Considered a responder to steroid therapy if alive, no heart failure hospitalization and no sustained ventricular arrhythmia, and improvement in one or both of:

  1. LV function (defined as 5% increase in EF units or 10% decrease in volumes)
  2. 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)
Same as current
Complete list of historical versions of study NCT01210677 on ClinicalTrials.gov Archive Site
Change in disease activity by PET imaging [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  1. Change in disease activity as assessed by PET imaging (comparing pre-treatment to 3 month scans)
  2. Atrial fibrillation burden during the 3 month treatment period (from pacemaker or ICD diagnostics)
  3. Ventricular arrhythmia burden during the 3 month treatment period
  4. Percent of ventricular pacing (pacemaker programming will be standardized in all patients)
  5. Patient Quality of life (using SF-36 questionnaire)
Same as current
Not Provided
Not Provided
 
Cardiac Sarcoidosis Response To Steroids Trial
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cardiac Sarcoidosis
  • Sarcoidosis
Drug: Prednisone
Prednisone 0.5 mg/Kg orally per day for 3 months
  • Active Comparator: Prednisone
    Prednisone 0.5 mg/Kg per day orally for 3 months
    Intervention: Drug: Prednisone
  • Placebo Comparator: Placebo
    Matching placebo tablets(s) taken orally per day
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01210677
UOHI-03
No
David Birnie, University of Ottawa Heart Institute
Ottawa Heart Institute Research Corporation
Not Provided
Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
Principal Investigator: Pablo B. Nery, MD Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP