Cardiac SarcoidosisPhase 4CASTORNCT01210677
Cardiac Sarcoidosis Response To Steroids Trial
A Phase 4 study testing Prednisone in people with Cardiac Sarcoidosis and Sarcoidosis, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis, Sarcoidosis
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial
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
- Being tested
- Prednisone
- Keywords
- Cardiac Sarcoidosis, Sarcoidosis
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Prednisone 0.5 mg/Kg orally per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Prednisone 0.5 mg/Kg per day orally for 3 months Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Matching placebo tablets(s) taken orally per day Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: No funding obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Birnie, Ottawa Heart Institute Research Corporation
- Investigators
- David Birnie, MD, Principal investigator, Ottawa Heart Institute Research CorporationPablo B. Nery, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210677
- Sponsor's protocol ID
- UOHI-03
- Acronym
- CASTOR
- Status last verified
- Oct 2013
- First submitted
- 27 Sep 2010
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial
- ClinicalTrials.gov ID
- NCT01210677
- Acronym / sponsor ID
- CASTOR / UOHI-03
- Conditions
- Cardiac Sarcoidosis, Sarcoidosis
- Keywords
- Cardiac Sarcoidosis, Sarcoidosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: PrednisonePrednisone 0.5 mg/Kg per day orally for 3 months |
| Placebo | Placebo comparator | Drug: PrednisoneMatching placebo tablets(s) taken orally per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisonePrednisone 0.5 mg/Kg orally per day for 3 months | Drug | Placebo, Prednisone |
Primary outcome
Heart failure hospitalization and sustained ventricular arrhythmia
Time frame: 3 months
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)
1 secondary outcome
Change in disease activity by PET imaging
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Birnie, MD principal investigator
Ottawa Heart Institute Research Corporation
Pablo B. Nery, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Cardiac Sarcoidosis and Sarcoidosis, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure hospitalization and sustained ventricular arrhythmia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.