Enhanced Screening Protocol for Cardiac Sarcoidosis

(PAPLAND Trial)

Recruiting at 12 trial locations

Overseen By Timothy Legenzoff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for Sarcoidosis Research

Disqualifiers: Cardiac sarcoidosis, Severe sarcoidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

1000 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{7 8 9 11 12}

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

I have been diagnosed with sarcoidosis according to official guidelines.

First visit to the enrolling center

Intent to continue care at the enrolling center at least annually

Exclusion Criteria

You have been referred to the study center for further evaluation of possible heart sarcoidosis.

You are not able or willing to have an ultrasound and wear a portable ECG device.

I have a severe condition that might cause death or require a transplant within a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Initial Screening

Participants undergo initial screening with echocardiogram and ambulatory ECG

Day 1

1 visit (in-person)

Follow-up Screening

Participants receive follow-up screening with echocardiogram and ambulatory ECG at 24 months

24 months

1 visit (in-person)

Routine Follow-up

Participants undergo routine follow-up with symptom assessment and ECG

12 months

1 phone call/chart review

Long-term Follow-up

Participants are monitored for cardiac sarcoidosis diagnosis over a long-term period

Up to 120 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Screening Protocol for Cardiac Sarcoidosis
• Routine Screening for Suspected Cardiac Sarcoidosis

Trial Overview The study compares routine screening (patient history and ECG) versus an enhanced protocol (additional echocardiogram and ambulatory ECG) in detecting cardiac sarcoidosis. Patients without initial signs will be randomly assigned either usual follow-up or enhanced screening at enrollment and after 24 months.

How Is the Trial Designed?

Group I: Routine Screening for Suspected Cardiac Sarcoidosis Experimental Treatment 1 Intervention

Arm will be randomly assigned for the routine standard of care/no intervention with enhanced screening methods. They will be offered the EKG and symptom check at months 0 and 24, as well as a phone call/chart review at month 12.

Group II: Enhanced Screening Protocol For Cardiac Sarcoidosis Experimental Treatment 1 Intervention

Arm will be randomly assigned to undergo enhanced screening methods (ambulatory ECG and echocardiogram) at month 0 and month 24, as well as a phone call/chart review at month 12.

Who Is Running the Clinical Trial?

Foundation for Sarcoidosis Research

Lead Sponsor

Trials

5

Recruited

8,100+

Published Research Related to This Trial

This case study highlights the importance of early diagnosis and monitoring of cardiac sarcoidosis, as significant progression can occur even in asymptomatic patients, demonstrated by a 4-year follow-up showing increased cardiac lesions without initial symptoms.

The combination of cardiac magnetic resonance (CMR) and 18F-FDG PET-CT imaging proved valuable in tracking the evolution of cardiac sarcoidosis, suggesting that these imaging techniques can enhance patient management and awareness of potential severe complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural evolution of cardiac sarcoidosis in an asymptomatic patient: a case report. Degtiarova, G., Gheysens, O., Van Cleemput, J., et al.[2022]

The CASPA study aims to determine the prevalence of cardiac sarcoidosis (CS) in patients with pulmonary sarcoidosis using advanced imaging techniques like MRI and echocardiography, which could lead to better diagnostic pathways.

Participants will undergo comprehensive cardiac assessments, including MRI, echocardiography, and Holter monitoring, along with serum protein analysis, to identify potential biomarkers associated with CS, enhancing understanding and management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CASPA (CArdiac Sarcoidosis in PApworth) improving the diagnosis of cardiac involvement in patients with pulmonary sarcoidosis: protocol for a prospective observational cohort study. Quijano-Campos, JC., Williams, L., Agarwal, S., et al.[2021]

In a study of 1017 Caucasian patients with sarcoidosis, an abnormal ECG was found in 16.3% of patients, and those with an abnormal ECG had a significantly higher risk of developing cardiac sarcoidosis (CS), with 13.2% later diagnosed with CS compared to only 0.1% of those with a normal ECG.

Patients exhibiting both abnormal ECG results and cardiac-related symptoms had an even higher risk of CS (27.5%), highlighting the importance of these factors in early screening and diagnosis, while those with Löfgren's syndrome showed a reduced risk for CS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac involvement in Caucasian patients with pulmonary sarcoidosis. Darlington, P., Gabrielsen, A., Sörensson, P., et al.[2022]

Cardiac sarcoidosis can occur in over 20% of patients with sarcoidosis, often without prior symptoms, and is a significant cause of sudden death due to arrhythmias or conduction defects.

Diagnosis is challenging, typically relying on advanced imaging techniques like PET/CT and MRI, and treatment primarily involves corticosteroids, with implantable cardioverter-defibrillators recommended for patients at risk of serious arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac involvement in sarcoidosis: evolving concepts in diagnosis and treatment. Lynch, JP., Hwang, J., Bradfield, J., et al.[2021]

Trans-thoracic Echocardiography (TTE) is useful for initial screening of Cardiac Sarcoidosis (CS) and can detect subclinical Left Ventricular dysfunction, but it has limited sensitivity and specificity for diagnosing CS.

Cardiac Magnetic Resonance Imaging (CMR) and Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) are crucial for diagnosing CS, with CMR identifying myocardial scarring and FDG-PET detecting active inflammation, guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging in Suspected Cardiac Sarcoidosis: A Diagnostic Challenge. Ha, FJ., Agarwal, S., Tweed, K., et al.[2021]

Nurses demonstrated a moderate level of agreement with medical residents in identifying adverse events (AEs), with a total agreement rate of 78.9% and a Kappa coefficient of 0.55, indicating reliable screening performance.

Nurses were more effective than medical residents in detecting certain screening criteria for AEs, confirming 179 true AEs compared to 171 by residents, highlighting the importance of their role in patient safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and accuracy of the screening for adverse events in Brazilian hospitals. Pavão, AL., Camacho, LA., Martins, M., et al.[2016]

In a review of 26 cancer treatment trials involving 75,598 routine adverse events (RAEs), only 3% were severe or life-threatening, indicating that most RAEs collected are not clinically significant.

The study suggests that 72% of RAEs could be eliminated from monitoring without compromising patient safety or the evaluation of treatment regimens, highlighting the potential for more efficient data collection in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials. Mahoney, MR., Sargent, DJ., O'Connell, MJ., et al.[2007]

Adverse events (AEs) in medical patients are frequent and costly, highlighting the need for effective screening methods to identify and reduce their occurrence.

While generic screening criteria can help identify AEs, they often trade off sensitivity for specificity, and no single method is highly effective; however, combining different screening techniques may enhance overall detection and contribute to quality improvement in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for adverse events. Karson, AS., Bates, DW.[2019]

Adverse event narratives are crucial for establishing the safety profile of a drug during clinical trials, as they provide detailed accounts of any negative experiences reported by participants.

These narratives help researchers and sponsors analyze serious adverse events, ensuring that all potential risks associated with a drug are thoroughly evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of serious adverse event: Writing a narrative. Nambiar, I.[2020]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Cardiac sarcoidosis (CS) can lead to serious complications like sudden cardiac death due to arrhythmias, but early detection through a combination of history, clinical examination, and ECG can identify up to 85% of cases.

Early immunosuppression in patients with CS can significantly reduce the risk of conduction abnormalities and supraventricular arrhythmias, highlighting the importance of prompt management in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac sarcoidosis - an expert review for the chest physician. Ho, JSY., Chilvers, ER., Thillai, M.[2020]

Cardiac involvement occurs in about 5% of sarcoidosis patients, often leading to serious issues like conduction abnormalities, arrhythmias, and heart failure, highlighting the need for careful monitoring.

Screening for cardiac sarcoidosis is crucial for all patients with extracardiac sarcoidosis and should also be considered in young patients with unexplained conduction issues, as cardiac symptoms may be the first sign of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac sarcoidosis - clinical manifestation and diagnosis]. Błaut-Jurkowska, J., Podolec, P., Olszowska, M.[2017]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Natural evolution of cardiac sarcoidosis in an asymptomatic patient: a case report. [2022]

2. England pubmed.ncbi.nlm.nih.gov

CASPA (CArdiac Sarcoidosis in PApworth) improving the diagnosis of cardiac involvement in patients with pulmonary sarcoidosis: protocol for a prospective observational cohort study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Cardiac involvement in Caucasian patients with pulmonary sarcoidosis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiac involvement in sarcoidosis: evolving concepts in diagnosis and treatment. [2021]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Imaging in Suspected Cardiac Sarcoidosis: A Diagnostic Challenge. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Reliability and accuracy of the screening for adverse events in Brazilian hospitals. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Screening for adverse events. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Analysis of serious adverse event: Writing a narrative. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

11. England pubmed.ncbi.nlm.nih.gov

Cardiac sarcoidosis - an expert review for the chest physician. [2020]

12. Poland pubmed.ncbi.nlm.nih.gov

[Cardiac sarcoidosis - clinical manifestation and diagnosis]. [2017]