An observational study in Cardiac Sarcoidosis, sponsored by Heart Center Leipzig - University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Heart Center Leipzig - University Hospital · Observational
Among 15 studies in Sarcoidosis with a site in Germany — 3 open to participants now, 4 under way, 1 of them phase 3. Sarcoidosis · Germany.
Among the 15 studies in Sarcoidosis with a site in Germany, this one is one of 2 that started in 2023, is one of 4 observational ones, and was the 11th registered.
271 studies on the registry are indexed under Sarcoidosis; 51 are open to participants now.
This study's planned enrollment of 100 is below the median of 130 across 109 observational studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →3 of the 15 studies in Sarcoidosis with a site in Germany are open now, in 8 countries. Each count lists the studies.
Of the 40 Sarcoidosis studies recruiting now, 30 (75%) set no upper age limit and 1 (3%) stop at 75 or younger; 6 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2023.
Median enrollment 166 across the 11 interventional studies, 75 across the 4 observational. Of the 8 that completed or were terminated, 5 (63%) have results posted.
8 of 15 have an industry lead sponsor. The 10 most frequent:
Heart Center Leipzig - University Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Heart Center Leipzig - University Hospital has 2 studies filed under Sarcoidosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Sarcoidosis with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06205121Molecure S.A.Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis | 2027-08 |
Among the 15 studies in Sarcoidosis with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of cardiac sarcoidosis.
Sarcoidosis is an inflammatory condition rarely affecting the heart, exhibiting fluctuating disease activity and eventually leading to ventricular fibrosis. Clinical presentation ranges from no symptoms at all to life-threatening arrhythmias, heart failure and death in severe cases. The heart lesions show patchy distribution and can mimic virtually any other type of cardiomyopathy, which poses significant challenges for the accurate and eary diagnosis.
At present, there are four diagnostic tools and recomendations for diagnosis of cardiac sarcoidosis (CS) that utilize clinical, ECG, laboratory, imaging and biopsy criteria. Recently, it was demonstrated that there is a significant diagreement between these four diagnostic tools. On the other hand, earlier identification of patients with active inflammatory process is necessary, as they are those who will most likely benefit from immunosuppressive therapy.
The aim of this observational study is to evaluate the prognostic significance of the current clinical, ECG, laboratory, imaging and biopsy criteria for diagnosing cardiac sarcoidosis. Patients with suspected cardiac sarcoidosis based on clinical symptoms will recieve elaborate diagnostic work-up consisting of: evaluation of symptoms, family history, occupational hazards, ECG, chest X-ray, laboratory markers for sarcoidosis, positron emission tomography (PET), cardiac magnetic resonance (CMR) as well as endomyocardial biopsy.
In accordance to the recomendations of the current guidelines, the patients will be devided into 3 groups: 1) patients with proven CS; 2) patients with probable CS; and 3) unlikely CS that will serve as a reference group. The patients in first two groups will be treated with immunosuppressive therapy, mainly glucocorticoids (GC). The follow-up at 3, 6, 12 and 24 months will consist of evaluation of the symptoms using dedicated King's Sarcoidosis Questionaire (KSQ), fatigue assessment scale (FAS), Holter-ECG, pacemaker interrogation, laboratory findings, imaging with PET and CMR.
Clinical outcomes will be defined as: 1) improvement of symptoms (FAS score, heart failure class, AV block, ventricular arrhythmias, and KSQ score) and 2) improvement of imaging parameters ( left ventricular ejection fraction, PET activity, myocardial edema, scar in CMR). The outcomes between the groups will be compared using group 3 as reference. Furthermore, patients with improvement with GC (successful therapy) will be compared with those without improvement (unsuccessful therapy) and the predictive value of each diagnostic criterion will be evaluated. Finally, the odds ratios (OR) for each parameter will be used to calculate a diagnostic and predictive score which will be used prospectively to evaluate patients with suspected CS and to guide the therapy.
Patients presenting at the Heart Center Leipzig, elective and urgent admissions
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
patients with suspected CS due to the following presentations:
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 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Cardiac mortality
Number of patients who died of cardiac reasons
Time frame: 2 years
All-cause mortality
Number of patients who died of cardiac or non-cardiac reasons
Time frame: 2 years
Unplanned hospitalizations
Number of unplanned hospitalizations due to heart failure or ventricular arrhythmias
Time frame: 2 years
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
Change in RV function
Measured in echocardiography or CMR as 10% change of RV EF, RV diameter, TAPSE
Time frame: 2 years
Patients' quality of life
A dedicated King's Sarcoidosis Questionnaire (KSQ) will be used to assess patients condition. Values from 1 to 100 define the patients' condition with higher scores indicating better condition. Improvement will be defined as increase of the KSQ score with at least 10 points.
Time frame: 2 years
VT ablation success
Applies only for patients after VT ablation: Time to VT recurrence
Time frame: 2 years
Adverse events of immunosuppressive therapy
Number of patients with significant adverse events related to the immunosuppressive therapy
Time frame: 2 years
Changes of immunosuppressive therapy due to lack of success
Number of GC dose increase and/or switch to another medication and/or escalation of therapy adding other immunosuppressive drugs to the GC
Time frame: 2 years
Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.
Of 59 non-industry observational studies under Sarcoidosis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 111. This study's planned 31 months is below that.
Counting every sponsor, half of 59 studies reached it within 49 months; a quarter within 20 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
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Heart Center Leipzig - University Hospital