Observing cardiac sarcoidosis in patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess patients with clinically manifest cardiac sarcoidosis (CS) and those with extra-cardiac sarcoidosis being screened for CS. It involves comprehensive baseline evaluations including medical history, imaging tests like echocardiograms and FDG-PET scans, and biomarker analysis. Patients will be followed up at intervals to monitor the progression of the disease and the effects of treatment, if applicable. The study seeks to fill the gap in understanding the clinical course of CS and the impact of corticosteroid therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To diagnose Clinically Manifest CS all following criteria must be met:

(i) Positive biopsy\* for Sarcoid (either EMB or extra-cardiac) AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) one or more of the following clinical features:

* 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

To diagnose clinically silent CS all of the following criteria must be met

(i) Biopsy proven extra-cardiac sarcoidosis

AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis

AND (iii) CMR suggestive of cardiac sarcoidosis

AND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following

* 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%)

Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control

Exclusion Criteria:

* unable or unwilling to provide informed consent
* patients who are pregnant or lactating
* patients with known claustrophobia
* age \< 18 years

Where it's running

• Libin Cardiovascular Institute of Alberta
  Calgary, Alberta, Canada Recruiting
• University of Alberta Hospital
  Edmonton, Alberta, Canada Recruiting
• St. Paul's Hospital
  Vancouver, British Columbia, Canada Recruiting
• QEII Health Sciences Center
  Halifax, Nova Scotia, Canada Recruiting
• Hamilton Health Sciences Centre
  Hamilton, Ontario, Canada Recruiting
• London Health Sciences Centre
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: David Birnie, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Janine E Ryan, BA(H), CCRP
• Email: jryan@ottawaheart.ca
• Phone: 613-696-7000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Al[18F]F-NOTA-folate PET imaging in suspected cardiac sarcoidosis and infective endocarditis

  This diagnostic test uses a folate-based PET tracer to see if it can help identify inflammation or infection in the heart for people with suspected cardiac sarcoidosis or infective endocarditis.

  Recruiting Turku University Hospital · Turku · NCT07814222

• Exosome-based biomarkers for cardiac sarcoidosis activity

  Researchers will test blood exosomes to see if they reveal activity of cardiac sarcoidosis in patients with and without the condition, using usual care FDG-PET data.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07604220

• Using advanced heart MRI to improve diagnosis and risk prediction for rare cardiomyopathies

  This project tests whether advanced cardiac MRI techniques can help diagnose and predict future risk for people with rare heart muscle diseases like Danon, Fabry, cardiac amyloidosis, Noonan syndrome, and cardiac sarcoidosis.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07336394

• Tc-99m Tilmanocept SPECT/CT imaging for detecting cardiac sarcoidosis

  This trial tries to see if a Tc-99m Tilmanocept SPECT/CT scan can detect cardiac sarcoidosis in adults.

  Recruiting Phase 2 Duke University · Durham, North Carolina · NCT07159074

• Evaluating rilonacept for treating cardiac sarcoidosis

  This study tests if adding a new drug called rilonacept to regular treatment can help adults with cardiac sarcoidosis reduce inflammation in their hearts.

  Recruiting at 2 sites Phase 2 Mayo Clinic · Baltimore, Maryland and 1 other locations · NCT06660732

• Using SGLT1/2 inhibitors to improve heart imaging in healthy volunteers

  This study is testing whether a new diabetes medication can help improve heart imaging in healthy volunteers by better controlling how the heart uses sugar during scans.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT06510894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.