Evaluating diagnostic criteria for cardiac sarcoidosis

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 the accuracy of current diagnostic criteria for cardiac sarcoidosis, a rare inflammatory condition affecting the heart. Patients suspected of having cardiac sarcoidosis will undergo a comprehensive diagnostic work-up, including clinical evaluations, ECG, laboratory tests, imaging studies like PET and CMR, and endomyocardial biopsy. The study seeks to identify discrepancies among existing diagnostic tools and improve early identification of patients who may benefit from immunosuppressive therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients with suspected CS due to the following presentations:

  1. age \< 65 years and new higher degree AV block, causative coronary artery disease excluded
  2. age \< 65 years and new ventricular tachycardia, causative coronary artery disease excluded
  3. age \< 65 years and ventricular tachycardia, causative coronary artery disease excluded
  4. extracardiac sarcoidosis and cardiac involvement suggested (palpitations, abnormal ECG, abnormal echocardiography)

To diagnose CS one of the following diagnostic tools will be used:

A) World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG)

B) Heart Rhythm Society expert consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoidosis

C) Japanese Society of Nuclear Cardiology (JSNC)

Patients whit histological confirmation from myocardial tissue fullfil will be defined as proven CS. (Group 1)

Patients with clinical and imaging findings highly suggesting CS, but without histological confirmation from myocardial biopsy will be defined as probable CS (Group 2)

Patients who do not fullfil the criteria or exhibiting findings suggesting an alternative, more likely diagnosis, will be considered as unlikely CS (Group 3)

Exclusion Criteria:

* unable or unwilling to provide informed consent
* patients who are pregnant or lactating
* noncompliant patients refusing the recommended therapy
* age \< 18 years

Where it's running

• Heart Center of Leipzig
  Leipzig, Germany Recruiting

Study contacts

• Principal investigator: Borislav Dinov, MD — Heart Center Leipzig - University Hospital, Department Electrophysiology
• Study coordinator: Borislav Dinov, MD
• Email: borislav.dinov@helios-gesundheit.de
• Phone: +49 341 865 1431

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.