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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Cardiac Sarcoidosis
Sarcoidosis
Drug: Prednisone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 0
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210677

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
Principal Investigator: Pablo B. Nery, MD Ottawa Heart Institute Research Corporation
  More Information

No publications provided

Responsible Party: David Birnie, MD, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01210677     History of Changes
Other Study ID Numbers: UOHI-03
Study First Received: September 27, 2010
Last Updated: October 29, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Heart Institute Research Corporation:
Cardiac Sarcoidosis
Sarcoidosis

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2014