Cardiac sarcoidosis
Conditions
Interventions
None listed
Sponsors
Foundation for Sarcoidosis Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Papland: • Diagnosis of sarcoidosis as per ATS guidelines Promys: • Sarcoidosis as defined by WASOG/ATS/ERS guidelines -or- clinical scenario highly suspicious for isolated cardiac sarcoidosis in patients with no evident extra cardiac disease; • Suspected cardiac sarcoidosis as defined by suggestive symptoms, ECG, echocardiogram, ambulatory ECG monitoring, or advanced cardiac imaging studies, in the opinion of the principal investigator; Diagnostic suspicion for CS must have occurred less than 12 months prior to the date of enrollment. Biomarker substudy: • Sarcoidosis as defined by WASOG/ATS/ERS guidelines • Presence of cardiac sarcoidosis as defined by established criteria. • Willing to participate in a study that involves return visits with phlebotomy (9 moments)
Exclusion criteria
Exclusion criteria: Papland: • Referred to the enrolling center to evaluate for suspected cardiac sarcoidosis. • Pre-existing high suspicion for cardiac sarcoidosis, defined as having had cardiac MRI or cardiac PET scan ordered by other institutions. Promys: • No plans for routine follow-up at the enrolling center. • Extra-cardiac disease likely to interfere with follow-up (e.g. life-threatening pulmonary or neurologic sarcoidosis; or life-threatening non-sarcoidosis diseases likely to result in death within 12 months, in the opinion of the investigator. • Cardiac sarcoidosis diagnosed by the enrolling center more than 12 months prior to inclusion in the registry. • Treatment administered specifically for cardiac sarcoidosis more than 12 months prior to enrollment, regardless of location, and regardless of whether other organs were also treated, as long as CS was part of the treatment target, in the opinion of the investigator. • Currently listed for a heart transplant. Biomarker substudy: • All of the exclusion criteria listed for the overall registry • Presence of an active infiltrative cardiomyopathy with the exception of a sarcoidosis cardiomyopathy. • Patients with active angina, active acute coronary syndromes, or other cardiac diseases associated with elevated serum troponin. • Presence of crescendo angina or active myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PAPLAND • The rate of diagnosis/incidence of cardiac sarcoidosis in sarcoidosis patients who are not suspected to have cardiac involvement based on initial evaluation using history and ECG. PROMyS • Death or heart transplant; • Cardiac hospitalization; • Defibrillator therapy (appropriate and inappropriate); • Need for RFA; • Change in ejection fraction; • Proportion of patients requiring various medical therapies for management; • Cardiac events (heart block, VT, atrial arrhythmias, cardiac arrest); • Pacingpercentage. | — |
Secondary
| Measure | Time frame |
|---|---|
| . | — |
Countries
Netherlands
Outcome results
None listed