NCT01210677

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
3.5 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

September 27, 2010

Last Update Submit

October 29, 2013

Conditions

Cardiac SarcoidosisSarcoidosis

Keywords

Cardiac SarcoidosisSarcoidosis

Outcome Measures

Primary Outcomes (1)

  • 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: 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)

    3 months

Secondary Outcomes (1)

  • Change in disease activity by PET imaging

    3 months

Study Arms (2)

Prednisone

ACTIVE COMPARATOR

Prednisone 0.5 mg/Kg per day orally for 3 months

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Matching placebo tablets(s) taken orally per day

Drug: Prednisone

Interventions

PrednisoneDRUG

Prednisone 0.5 mg/Kg orally per day for 3 months

PlaceboPrednisone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • David Birnie, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Pablo B. Nery, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

December 1, 2016

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

CA(1)