Cardiac Sarcoidosis Response To Steroids Trial

Sarcoidosis Clinical Trial

— CASTOR  

Official title:

CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01210677
• Other study ID #: UOHI-03
• Status: Withdrawn
• Phase: Phase 4
• First received: September 27, 2010
• Last updated: October 29, 2013
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2013
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Sarcoidosis

Intervention

Drug:
• Prednisone
Prednisone 0.5 mg/Kg orally per day for 3 months

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months	No
Secondary	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)	3 months	No