Enhanced Screening Protocol for Cardiac Sarcoidosis

(PAPLAND Trial)

No longer 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

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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