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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 months after study completion
Awards & highlights

PAPLAND Trial 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.Check my eligibility
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.See study design
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.

PAPLAND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with sarcoidosis according to official guidelines.

PAPLAND Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Positive result from study cohort
Rate of diagnosis of cardiac sarcoidosis during standard of care of patient symptoms and ECG.

PAPLAND 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.

Find a Location

Who is running the clinical trial?

Foundation for Sarcoidosis ResearchLead Sponsor
4 Previous Clinical Trials
7,135 Total Patients Enrolled
Muhunthan Thillai, MBBSPrincipal InvestigatorRoyal Papworth Hospital
Dan Culver, DOPrincipal InvestigatorThe Cleveland Clinic

Media Library

Enhanced Screening Protocol for Cardiac Sarcoidosis (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03902223 — N/A
Cardiac Sarcoidosis Research Study Groups: Enhanced Screening Protocol For Cardiac Sarcoidosis, Routine Screening for Suspected Cardiac Sarcoidosis
Cardiac Sarcoidosis Clinical Trial 2023: Enhanced Screening Protocol for Cardiac Sarcoidosis Highlights & Side Effects. Trial Name: NCT03902223 — N/A
Enhanced Screening Protocol for Cardiac Sarcoidosis (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03902223 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many persons are slated to participate in this experiment?

"Affirmative, the clinicaltrials.gov website attests to this study's active recruitment of patients which commenced on April 5th 2019 and was last edited in August 12th 2019. The trial requires 600 participants across 10 sites."

Answered by AI

Are there numerous medical facilities across the state conducting this clinical investigation?

"The University of Iowa Hospital in Iowa City, Cleveland Clinic in Ohio, and Penn Medicine in Philadelphia are amongst the 11 medical centres that are open to enrolling participants for this trial."

Answered by AI

Is this research endeavor currently accepting participants?

"Affirmative. According to clinicaltrials.gov, the announced clinical trial which debuted on April 5th 2019 is recruiting participants. To meet their goals they must enroll 600 patients at 10 different medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
National Jewish Health
University of Cincinnati Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Routine Cardiac Screening in Sarcoidosis Patients
2019. "Routine Cardiac Screening in Sarcoidosis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03902223.
All > Stronger Than Sarcoidosis > Sarcoidosis
~297 spots leftby Apr 2029
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