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Cardiac Sarcoidosis Response To Steroids Trial

NCT01210677 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-10-30

No results posted yet for this study

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

Conditions

  • Cardiac Sarcoidosis
  • Sarcoidosis

Interventions

DRUG

Prednisone

Prednisone 0.5 mg/Kg orally per day for 3 months

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • David Birnie, MD · Ottawa Heart Institute Research Corporation

  • Pablo B. Nery, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210677 on ClinicalTrials.gov