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Diagnostic Criteria in Cardiac Sarcoidosis

Launched by HEART CENTER LEIPZIG - UNIVERSITY HOSPITAL · Feb 2, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how well the current methods for diagnosing cardiac sarcoidosis, a condition where small clusters of inflammatory cells form in the heart, actually work. The researchers want to see if the existing criteria can accurately identify patients with this condition, which can sometimes be difficult to diagnose. The study is currently recruiting participants aged 65 and older who are experiencing certain heart-related symptoms or have a history of sarcoidosis in other parts of the body.

To be eligible for the trial, participants must have specific heart issues or symptoms that suggest cardiac sarcoidosis, such as new heart rhythm problems or signs of heart involvement linked to previous sarcoidosis. During the study, doctors will use different diagnostic tools to evaluate participants and determine whether they have proven, probable, or unlikely cardiac sarcoidosis based on their symptoms and test results. If you or someone you know has these symptoms and is interested in participating, this trial could help improve how doctors diagnose this complex condition in the future.

Gender

ALL

Eligibility criteria

  • 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

About Heart Center Leipzig University Hospital

Heart Center Leipzig - University Hospital is a leading medical institution specializing in cardiovascular care and research. Renowned for its commitment to advancing heart health, the center integrates cutting-edge clinical practices with innovative research initiatives. As a prominent clinical trial sponsor, it focuses on developing and evaluating new therapeutic strategies and technologies aimed at improving patient outcomes in cardiovascular diseases. The Heart Center Leipzig is dedicated to fostering collaboration between clinicians, researchers, and industry partners to enhance the understanding and treatment of heart conditions, ultimately contributing to global advancements in cardiovascular medicine.

Locations

Leipzig, , Germany

Patients applied

0 patients applied

Trial Officials

Borislav Dinov, MD

Principal Investigator

Heart Center Leipzig - University Hospital, Department Electrophysiology

Laura Ueberham, MD

Study Chair

Heart Center Leipzig - University Hospital, Department Electrophysiology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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