Actively Recruiting
Cardiomyocyte Specific Cell Free DNA as a Marker of Cardiac Sarcoidosis
Led by Nabeel Hamzeh · Updated on 2026-01-09
120
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sarcoidosis is a disease that causes granulomas, or clusters of immune cells, in various organs including the heart. This condition can lead to heart muscle inflammation called granulomatous myocarditis, which may cause heart dysfunction and abnormal heart rhythms, potentially resulting in serious health problems or death. Immunosuppressive therapy has been shown to help reverse this inflammation and improve heart function. However, current biomarkers and imaging methods to detect active myocarditis are limited in accuracy or practicality, highlighting the need for better diagnostic tools. This research explores the use of cell free DNA (cfDNA), which are fragments of DNA released from damaged heart cells, as a potential biomarker to identify active heart inflammation in sarcoidosis patients. The study involves different groups including sarcoidosis patients with and without active myocarditis, patients with acute heart attacks, and healthy controls. Participants will provide blood samples at various times to measure cfDNA levels, aiming to distinguish active heart inflammation from other conditions. Participants will be involved in blood draws according to group assignments, such as single or multiple samples over hours or months. Researchers will assess cfDNA levels and compare them among groups to understand their relationship with active myocarditis. The study will monitor participants through clinical evaluations and laboratory testing, aiming to improve methods for detecting heart involvement in sarcoidosis and guide future treatment decisions. The trial is planned to continue until June 2028.
CONDITIONS
Brief Title
Cell Free DNA in Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of sarcoidosis based on ATS/ERS criteria for sarcoidosis groups
- Normal 12 lead ECG in past year for sarcoidosis without active myocarditis
- Non-smoker status for sarcoidosis groups and healthy controls
- No immunosuppressive therapy for at least one year for sarcoidosis without active myocarditis
- Evidence of active myocarditis by recent cardiac MRI or FDG-PET for sarcoidosis with active myocarditis
- Diagnosis of STEMI based on ST elevation in 2 or more leads for STEMI group
- Symptom onset within 12 hours for STEMI group
- Undergoing cardiac intervention for acute coronary syndrome for STEMI group
- Ability to consent for blood draw for STEMI group
- No known cardiac disease or cardiovascular risk factors for healthy controls
You will not qualify if you...
- Known cardiac disease for sarcoidosis without active myocarditis and healthy controls
- Active smoking status for sarcoidosis groups, STEMI group
- On immunosuppressive therapy for sarcoidosis groups
- Known cardiac disease other than sarcoidosis for sarcoidosis with active myocarditis
- Hemodynamically unstable for STEMI group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months depending on group
Participants have blood draws to measure cell free DNA levels to identify cardiac injury related to sarcoidosis or myocardial infarction.
1 to 3 visits depending on group assignment
Trial Site Locations
Total: 2 locations
1
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
B
Brenda Werner, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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