The aim of the study is in threefold: Firstly, examine whether conventional screening for cardiac involvement based on history and ECG followed by routine use of echocardiogram with strain and Holter monitoring will identify more patients with…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
.
Background summary
Cardiac involvement is the second leading cause of death in patients with
sarcoidosis. Knowledge about the natural history of the disease and early
diagnosis is important for adequate clinical management.
Study objective
The aim of the study is in threefold: Firstly, examine whether conventional
screening for cardiac involvement based on history and ECG followed by routine
use of echocardiogram with strain and Holter monitoring will identify more
patients with cardiac sarcoidosis compared to screening based on conventional
screening alone. In addition, we aim to examine the sensitivity of detecting
cardiac sarcoidosis using conventional screening and determining the rate of
diagnosis of cardiac sarcoidosis in sarcoidosis patients who had initial
negative conventional and second-tier screening tests after undergoing these
screening tests again at 24 months. Secondly, we aim to define the natural
history of cardiac sarcoidosis in a broad sarcoidosis population, identify
prognostic predictors, assess whether suspected isolated cardiac sarcoidosis
behaves differently than conventional cardiac sarcoidosis and assess the
implications of abnormal screening tests in individuals without advanced
imaging (MRI, PET) abnormalities. Thirdly, we aim to evaluate the effect of
anti-sarcoidosis therapy for cardiac sarcoidosis and evaluate the change in
serum levels of Troponin T Gen 5, and NT-proBNP with reductions in
anti-sarcoidosis therapy for cardiac sarcoidosis.
Study design
This study will have two arms: a screening (PAPLAND) and registry-arm (PROMyS).
PAPLAND is a prospective randomized un-blinded trial for cardiac sarcoidosis
comparing the addition of echocardiogram with strain and Holter monitoring to
conventional clinical follow-up. The PROMyS-arm consists of a prospective
multicenter registry of suspected and confirmed cardiac sarcoidosis patients
and biomarker sub study.
Study burden and risks
PAPLAND-arm: The use of (ambulatory) ECG and echocardiogram pose no risk, since
these tests are noninvasive, do not use radiation and are painless. It is,
however, possible that patients experience skin irritations from gel or paste
used to attach the electrodes. In addition, prolonged contact with these
electrodes may also cause skin irritation. Nevertheless, we do not expect
serious complications caused by these tests. The use of cardiac MRI also is not
harmful for patients based on the fact that no radiation is required for this
kind of imaging.
Biomarker sub study: venous blood samples are needed. Venipuncture is a
procedure with minimal risks. Patients may however, experience inconveniences
during and after blood draw, for example: hematoma, pain in the arm, etc.
W. Webster Avenue, Suite 304 1820
Chicago, IL 60614
US
W. Webster Avenue, Suite 304 1820
Chicago, IL 60614
US
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71111.100.19 |