1500 Participants NeededMy employer runs this trial

Corticosteroids for Cardiac Sarcoidosis

(CHASM-CS Trial)

Recruiting at 14 trial locations
KM
DB
JE
Overseen ByJanine E Ryan, BA(H), CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
Must be taking: Corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore better ways to diagnose and treat cardiac sarcoidosis (CS), a condition where small clusters of cells cause heart problems. Researchers seek to determine if corticosteroid therapy can improve symptoms and outcomes for people with CS. The trial will also evaluate the effectiveness of implanting a defibrillator, a device that helps control irregular heartbeats. Suitable participants include those with a confirmed diagnosis of sarcoidosis and heart-related symptoms, such as irregular heart rhythms or heart muscle issues.

As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to potentially groundbreaking advancements in CS care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that short-term corticosteroid therapy is generally safe, though mild side effects can occur. Long-term use may lead to more serious issues, so weighing the benefits and risks is important. High doses of corticosteroids are safe when used properly, but regular check-ups are recommended to monitor for side effects.

Research has shown that implanting a defibrillator can be done safely. Risks include infection, swelling, or bleeding at the implant site, but these are usually manageable. The device effectively detects and stops dangerous heart rhythms. Overall, both treatments have a history of being well-tolerated under medical supervision.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for cardiac sarcoidosis because they address different aspects of the condition. Corticosteroid therapy is unique because it directly reduces inflammation, which is a hallmark of sarcoidosis, potentially offering more immediate relief compared to traditional anti-inflammatory treatments. On the other hand, the implantation of a defibrillator provides a proactive approach to managing the risk of sudden cardiac events, which are a serious concern for patients with this condition. This dual approach of reducing inflammation and managing cardiac risks sets these treatments apart from the standard of care, offering a more comprehensive strategy for tackling cardiac sarcoidosis.

What evidence suggests that this trial's treatments could be effective for cardiac sarcoidosis?

Studies have shown that corticosteroid therapy can reduce the risk of death in patients with severe illnesses, suggesting potential benefits for cardiac sarcoidosis (CS). Although specific data on CS is limited, corticosteroids have improved outcomes in other serious conditions. Conversely, implantable cardioverter-defibrillators (ICDs) have been proven to prevent sudden cardiac death. Research indicates that ICDs significantly lower the risk of death in at-risk patients. This trial will explore the combined use of these treatments as a promising approach to managing CS, but more specific studies are needed to confirm their effectiveness for this condition.678910

Who Is on the Research Team?

PN

Pablo Nery, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

RB

Rob Beanlands, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

DB

David Birnie, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
non- sustained or sustained ventricular arrhythmia
ventricular dysfunction (LVEF < 50% and/or RVEF < 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months
Multiple visits for baseline assessments

Baseline Assessment

Baseline assessment of Clinically Manifest CS patients includes history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers, cardiac MRI, and possibly a signal average ECG and biopsy.

2 months

Treatment

Treatment with steroids/immunosuppressants and device therapy at the discretion of the treating physician.

6 months

Follow-up

Follow-up and clinical management of clinically manifest patients diagnosed with CS will occur at 3-6 months with a repeat FDG-PET scan and blood biomarkers. Follow-up will then be annually with an echo and ECG.

4 years
Annual visits

Long-term Follow-up

All patients will be followed until the last patient recruited has been followed for 4 years. Clinically Silent patients will be contacted every 2 years, and extra-cardiac sarcoidosis patients will be contacted at 5 years and at the time of study completion.

9 years

What Are the Treatments Tested in This Trial?

Interventions

  • Corticosteroid Therapy
  • Implantation of a defibrillator

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Ontario Ministry of Health and Long Term Care

Collaborator

Trials
92
Recruited
108,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Citations

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Conclusions: Corticosteroids have proven to be an effective treatment for COVID-19 patients in critical condition. However, comparative ...

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Early initiation of corticosteroids was associated with significantly improved outcomes, with 100% survival, compared to late initiation (after ...

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Corticosteroid treatment was associated with better ventilator and intensive-care unit free days. A significant decrease in mortality was observed with ...

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Corticosteroids reduced short-term mortality in critically ill patients compared to placebo (RR, 0.85; 95% CI, 0.77–0.94).

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Results showed that corticosteroids were associated with a decreased all-cause mortality (27.3 vs. 31.1%; RR: 0.85; 95% CI: 0.73–0.99; P = 0.04; ...

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This study demonstrates that high dose corticosteroids is safe and should be used when clinically indicated.

Corticosteroid Adverse Effects - StatPearls - NCBI Bookshelf

While short-term use of corticosteroids is associated with mild side effects, long-term use can result in several severe adverse effects, some ...

Prednisone and other corticosteroids: Balance the risks ...

If you're taking long-term corticosteroid therapy, see your provider regularly to check for side effects. Weigh the risks and benefits of corticosteroids.

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A practical guide to the monitoring and management of the ...

Safety of low dose glucocorticoid treatment in rheumatoid arthritis: published evidence and prospective trial data. Ann Rheum Dis. 2006;65:285–293. doi ...