Enhanced Screening Protocol for Cardiac Sarcoidosis
(PAPLAND Trial)
Trial Summary
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 data supports the idea that Enhanced Screening Protocol for Cardiac Sarcoidosis is an effective treatment?
The available research shows that Enhanced Screening Protocol for Cardiac Sarcoidosis is important because cardiac sarcoidosis can be life-threatening and often goes unnoticed until it's too late. The research highlights the importance of early detection using advanced imaging techniques like MRI and PET scans, which are crucial for diagnosing cardiac sarcoidosis. Although there are no randomized trials, the use of corticosteroids and other treatments is common, and early screening can help prevent serious outcomes like sudden cardiac death. This makes the Enhanced Screening Protocol a valuable approach for managing the condition.12345
What safety data exists for the Enhanced Screening Protocol for Cardiac Sarcoidosis?
The provided research does not directly address safety data specific to the Enhanced Screening Protocol for Cardiac Sarcoidosis or its alternative names. However, it discusses general methods for tracking and analyzing adverse events (AEs) in clinical trials, which are crucial for assessing patient safety. These methods include routine screening for AEs, the use of web-based systems for tracking minor AEs, and the importance of evaluating serious AEs through detailed narratives. While these studies highlight the importance of AE monitoring in clinical trials, specific safety data for the Enhanced Screening Protocol for Cardiac Sarcoidosis is not mentioned.678910
Is the Enhanced Screening Protocol for Cardiac Sarcoidosis a promising treatment?
Yes, the Enhanced Screening Protocol for Cardiac Sarcoidosis is promising because it uses advanced imaging techniques and tests to better detect heart problems early in patients with sarcoidosis. This can help prevent serious issues like heart failure or sudden death by identifying those who need further treatment sooner.2351112
What is the purpose of this trial?
This protocol is an unblended randomized screening trial will have consecutive patients with no suggestion of cardiac sarcoidosis according to usual screening enroll in an enhanced screening protocol. The routine clinical care is to gather patient's history of symptoms and under go an ECG. If a patient has an abnormal results in standard screening, they typically have further evaluations as part of their routine medical care. These tests might include an echocardiogram, ambulatory ECG, and advanced cardiac imaging (MRI, PET scan as per local practice). A patient that has normal results on standard screening will be randomly assigned to enhanced screening at each center. Half the patients will be randomized to usual follow-up (annual symptom assessment and ECG) and the other half will be assigned to the enhanced screening (echocardiogram and ambulatory ECG at enrollment and at 24 months).The investigators hypothesize that screening using conventional history, physical and ECG in the general sarcoidosis population, followed by appropriate advanced imaging testing, will result in the identification of a higher percentage of ascertained cardiac sarcoidosis than has been reported historically (2-5%). The investigators hypothesize that routine use of echocardiogram with strain and ambulatory ECG will identify additional patients who will have advanced imaging abnormalities or who meet criteria for cardiac sarcoidosis. The investigators further hypothesize that re-screening patients after 24 months with repeat echocardiogram and ambulatory ECG will identify additional patients with suspicion for cardiac sarcoidosis who had no abnormalities on the standard screening tests.
Research Team
Dan Culver, DO
Principal Investigator
The Cleveland Clinic
Muhunthan Thillai
Principal Investigator
Royal Papworth Hospital
Eligibility Criteria
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
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
Treatment Details
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