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Diagnostic Criteria in Cardiac Sarcoidosis

ConditionCardiac Sarcoidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Center Leipzig - University Hospital

About this trial

The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of cardiac sarcoidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age < 65 years and new higher degree AV block, causative coronary artery disease excluded

age < 65 years and new ventricular tachycardia, causative coronary artery disease excluded

age < 65 years and ventricular tachycardia, causative coronary artery disease excluded

extracardiac sarcoidosis and cardiac involvement suggested (palpitations, abnormal ECG, abnormal echocardiography)

Disqualifiers

unable or unwilling to provide informed consent

patients who are pregnant or lactating

noncompliant patients refusing the recommended therapy

age < 18 years

Trial population

Patients presenting at the Heart Center Leipzig, elective and urgent admissions

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ECG, Echo, laboratory tests, CMR, PET-CT, Biopsy

    Diagnostic test

    ECG - 12 leads ECG Echo: transthoracic echocardiography laboratory tests: full blood count, electrolytes, creatinine, high sensitive cardiac troponin T, angiontesin converting enzyme, soluble interleukin-2 receptor, cardiac magnetic resonance imaging: 1.5 Tesla scanner, Conventional cine imaging and late gadolinium enhancement imaging PET-CT: 18F-fluorodeoxyglucose (FDG)- positron emission tomograph Biopsy: cardiac biopsy = endomyocardial biopsy, left and right ventricle, at least 5 specimens in formaldehyd and 3 specimens for testing of infectious agents Biopsy: extracardiac biopsy, as accessible according to imaging

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clinical recovery with immunosuppressive therapy

Number of patients showing clinical recovery defined as improvement of at least one of the following: decrease of the heart failure class, decrease of fatigue assessed by FAS score, increase of KSQ score with at least 10 points, reduction of burden of ventricular arrhythmias assessed with Holter ECG or device interrogations, improvement of the AV block

Time frame
1 year
2

Imaging recovery with immunosuppressive therapy

Number of patients with improvement of the cardiac imaging defined as one of the following: increase of the EF with at least 10%, decrease of the PET activity, decrease of the scar or edema in CMR

Time frame
1 year

Secondary outcomes

1

Cardiac mortality

Number of patients who died of cardiac reasons

Time frame
2 years
2

All-cause mortality

Number of patients who died of cardiac or non-cardiac reasons

Time frame
2 years
3

Unplanned hospitalizations

Number of unplanned hospitalizations due to heart failure or ventricular arrhythmias

Time frame
2 years
4

Change in LV-EF from baseline

Measured in echocardiography or CMR as at least 10% change of the LV EF, LV EDD

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Center Leipzig - University Hospital

Lead sponsor

Source ClinicalTrials.gov
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