Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04737317 |
Other study ID # |
20201231PV1 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
January 1, 2027 |
Study information
Verified date |
May 2023 |
Source |
Heart Center Leipzig - University Hospital |
Contact |
Borislav Dinov, MD |
Phone |
+49 341 865 1431 |
Email |
borislav.dinov[@]helios-gesundheit.de |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of
cardiac sarcoidosis.
Description:
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.