Cardiac Sarcoidosis Response To Steroids Trial (CASTOR)

This study is not yet open for participant recruitment.

Verified April 2013 by University of Ottawa Heart Institute

Sponsor:

Information provided by (Responsible Party):

David Birnie, University of Ottawa Heart Institute

ClinicalTrials.gov Identifier:

NCT01210677

First received: September 27, 2010

Last updated: April 3, 2013

Last verified: April 2013

History of Changes

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:

MedlinePlus related topics: Sarcoidosis Steroids

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by University of Ottawa Heart Institute:

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)

Estimated Enrollment:	30
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

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

Contacts

Contact: David Birnie, MD	613-761-4705	DBirnie@ottawaheart.ca
Contact: Pablo Nery, MD	613-761-4929	PNery@ottawaheart.ca

Locations

Canada, Ontario
University of Ottawa Heart Institute	Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Karen MacDonald, RN 613-798-5555 ext 17077 kmacdonald@ottawaheart.ca
Sub-Investigator: Pablo Nery, MD
Sub-Investigator: George Wells, PhD

Sponsors and Collaborators

University of Ottawa Heart Institute

Investigators

Principal Investigator:	David Birnie, MD	University of Ottawa Heart Institute
Principal Investigator:	Pablo B. Nery, MD	University of Ottawa Heart Institute

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:	April 3, 2013
Health Authority:	Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:

Cardiac Sarcoidosis
Sarcoidosis

Additional relevant MeSH terms:

Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013

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