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Cardiac Sarcoidosis Response To Steroids Trial

NCT ID: NCT01210677

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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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 Description

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Conditions

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Cardiac Sarcoidosis Sarcoidosis

Keywords

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Cardiac Sarcoidosis Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prednisone

Prednisone 0.5 mg/Kg per day orally for 3 months

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

Prednisone 0.5 mg/Kg orally per day for 3 months

Placebo

Matching placebo tablets(s) taken orally per day

Group Type PLACEBO_COMPARATOR

Prednisone

Intervention Type DRUG

Prednisone 0.5 mg/Kg orally per day for 3 months

Interventions

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Prednisone

Prednisone 0.5 mg/Kg orally per day for 3 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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David Birnie

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Birnie, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Pablo B. Nery, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UOHI-03

Identifier Type: -

Identifier Source: org_study_id