1000 Participants Needed

Enhanced Screening Protocol for Cardiac Sarcoidosis

(PAPLAND Trial)

Recruiting at 12 trial locations
GS
NS
TS
TL
Overseen ByTimothy Legenzoff
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Foundation for Sarcoidosis Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DC

Dan Culver, DO

Principal Investigator

The Cleveland Clinic

MT

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

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Routine Screening for Suspected Cardiac SarcoidosisExperimental Treatment1 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 SarcoidosisExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Foundation for Sarcoidosis Research

Lead Sponsor

Trials
5
Recruited
8,100+

Findings from Research

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

References

Natural evolution of cardiac sarcoidosis in an asymptomatic patient: a case report. [2022]
CASPA (CArdiac Sarcoidosis in PApworth) improving the diagnosis of cardiac involvement in patients with pulmonary sarcoidosis: protocol for a prospective observational cohort study. [2021]
Cardiac involvement in Caucasian patients with pulmonary sarcoidosis. [2022]
Cardiac involvement in sarcoidosis: evolving concepts in diagnosis and treatment. [2021]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Imaging in Suspected Cardiac Sarcoidosis: A Diagnostic Challenge. [2021]
Reliability and accuracy of the screening for adverse events in Brazilian hospitals. [2016]
Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials. [2007]
Screening for adverse events. [2019]
Analysis of serious adverse event: Writing a narrative. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]
Cardiac sarcoidosis - an expert review for the chest physician. [2020]
[Cardiac sarcoidosis - clinical manifestation and diagnosis]. [2017]
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