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Cardiac Sarcoidosis Response To Steroids Trial (CASTOR)

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ClinicalTrials.gov Identifier: NCT01210677
Recruitment Status : Withdrawn (No funding obtained.)
First Posted : September 28, 2010
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
David Birnie, Ottawa Heart Institute Research Corporation

Study Description
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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

Condition or disease Intervention/treatment Phase
Cardiac Sarcoidosis Sarcoidosis Drug: Prednisone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial
Study Start Date : April 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis Steroids
Drug Information available for: Prednisone

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Heart failure hospitalization and sustained ventricular arrhythmia [ Time Frame: 3 months ]

    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)


Secondary Outcome Measures :
  1. Change in disease activity by PET imaging [ Time Frame: 3 months ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210677


Locations
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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
Principal Investigator: Pablo B. Nery, MD Ottawa Heart Institute Research Corporation
More Information
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Responsible Party: David Birnie, MD, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01210677    
Other Study ID Numbers: UOHI-03
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013
Keywords provided by David Birnie, Ottawa Heart Institute Research Corporation:
Cardiac Sarcoidosis
Sarcoidosis
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents