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Diagnostic Test

Enhanced Screening Protocol for Cardiac Sarcoidosis (PAPLAND Trial)

N/A

Recruiting

Led By Muhunthan Thillai, MBBS

Research Sponsored by Foundation for Sarcoidosis Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of sarcoidosis as per The American Thoracic Society guidelines

Be older than 18 years old

Must not have

Severe sarcoidosis or other disease conferring a high likelihood of death or transplant within the next year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 months after study completion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new protocol to screen for cardiac sarcoidosis. 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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive screenings like ECGs and echocardiograms rather than medications, side effects are minimal but may include discomfort from wearing an ambulatory ECG device or anxiety from undergoing frequent testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with sarcoidosis according to official guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 months after study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 months after study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 months after study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positive result found from enhanced cardiac sarcoidosis screening at initial visit (sensitivity)

Positive result found from enhanced cardiac screening at month 24 (sensitivity)

Positive result found on enhanced cardiac screening at month 12 (sensitivity)

Secondary study objectives

Positive result from study cohort

Rate of diagnosis of cardiac sarcoidosis during standard of care of patient symptoms and ECG.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 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.

Group II: Routine Screening for Suspected Cardiac SarcoidosisActive Control1 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.

0 / 2Eligibility criteria met