Clinical Trial: Cardiac Sarcoidosis Response To Steroids Trial

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial

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

Detailed Summary:
Sponsor: Ottawa Heart Institute Research Corporation

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: 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)


Original Secondary Outcome: Same as current

Information By: Ottawa Heart Institute Research Corporation

Dates:
Date Received: September 27, 2010
Date Started: April 2014
Date Completion: December 2016
Last Updated: October 29, 2013
Last Verified: October 2013