Enhanced Screening Protocol for Cardiac Sarcoidosis
(PAPLAND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find better ways to screen for cardiac sarcoidosis, a condition where inflammation affects the heart. Participants will either follow the usual screening methods, such as checking symptoms and an ECG, or undergo enhanced screening, which includes additional heart tests like an echocardiogram and continuous heart monitoring. Researchers hope these extra tests will detect more cases of cardiac sarcoidosis than the usual methods. Good candidates for the trial are those diagnosed with sarcoidosis who are visiting the study center for the first time and plan to continue their care there annually.
As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could improve future screening methods for cardiac sarcoidosis.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the focus is on screening procedures rather than medication changes.
What prior data suggests that this enhanced screening protocol is safe for cardiac sarcoidosis patients?
Research has shown that advanced imaging tests, like those used in the improved screening process, effectively detect cardiac sarcoidosis. In one study with 114 patients, these tests diagnosed cardiac sarcoidosis in 36 patients, indicating that the improved screening methods can help detect the condition early.
Regarding safety, the improved screening uses non-invasive tests such as heart ultrasounds (echocardiograms) and portable heart monitors (ambulatory ECGs). Patients generally find these tests easy to handle, and they have been used in medical practice for a long time without major safety issues. The studies reviewed reported no serious problems from these screening methods, suggesting that the improved screening process should be safe for participants.12345Why are researchers excited about this trial?
Researchers are excited about the Enhanced Screening Protocol for Cardiac Sarcoidosis because it offers a more comprehensive approach to detecting the disease earlier and more accurately. Unlike routine screenings, which typically involve standard EKGs and symptom checks, this enhanced protocol includes ambulatory ECGs and echocardiograms, providing a deeper look into heart function and potential abnormalities. By catching signs of cardiac sarcoidosis sooner, this method might allow for earlier intervention and better outcomes for patients.
What evidence suggests that this enhanced screening protocol is effective for identifying cardiac sarcoidosis?
Research has shown that improved screening methods can identify more cases of cardiac sarcoidosis. One study found that advanced imaging techniques detected cardiac sarcoidosis in 36 out of 114 patients, a significant increase compared to usual methods. This trial will compare two approaches: the Enhanced Screening Protocol for Cardiac Sarcoidosis, which includes echocardiograms and portable heart monitors, and Routine Screening for Suspected Cardiac Sarcoidosis. Experts recommend these improved screenings because they can detect heart issues early, even if symptoms are mild or not noticeable. Early detection can lead to better management of the condition, potentially improving outcomes for those affected.12367
Who Is on the Research Team?
Dan Culver, DO
Principal Investigator
The Cleveland Clinic
Muhunthan Thillai
Principal Investigator
Royal Papworth Hospital
Are You a Good Fit for This Trial?
This trial is for sarcoidosis patients who plan to continue care at the enrolling center, are visiting for the first time, and meet American Thoracic Society guidelines for diagnosis. It's not for those with a high suspicion of cardiac sarcoidosis, unable to undergo specific heart tests, referred specifically for suspected heart involvement in sarcoidosis, or with severe disease likely leading to death or transplant within a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Screening
Participants undergo initial screening with echocardiogram and ambulatory ECG
Follow-up Screening
Participants receive follow-up screening with echocardiogram and ambulatory ECG at 24 months
Routine Follow-up
Participants undergo routine follow-up with symptom assessment and ECG
Long-term Follow-up
Participants are monitored for cardiac sarcoidosis diagnosis over a long-term period
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced Screening Protocol for Cardiac Sarcoidosis
- Routine Screening for Suspected Cardiac Sarcoidosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Foundation for Sarcoidosis Research
Lead Sponsor