Investigating cell-free DNA in cardiac sarcoidosis
Official title: Cardiomyocyte Specific Cell Free DNA as a Marker of Cardiac Sarcoidosis
Run by University of Iowa · NCT03858777 · Data updated 2026-11-12
This study is testing if cell-free DNA can help doctors detect active heart inflammation in people with sarcoidosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2019 |
| Main results expected | December 15, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT03858777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with sarcoidosis, particularly those with evidence of active myocarditis or acute ST elevation myocardial infarction.
✕Probably not a fit
Patients with known cardiac diseases unrelated to sarcoidosis or those currently on immunosuppressive therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore the role of cell-free DNA as a potential biomarker for detecting active myocarditis in patients with sarcoidosis. It will involve patients with diagnosed sarcoidosis, both with and without evidence of active myocarditis, as well as those experiencing acute ST elevation myocardial infarction. The methodology includes assessing patients through advanced imaging techniques and monitoring their response to immunosuppressive therapy. The goal is to improve the understanding and management of cardiac sarcoidosis, which can lead to severe complications.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment strategies for patients with cardiac sarcoidosis.
How similar studies have gone: While there have been studies exploring biomarkers in sarcoidosis, the specific approach of using cell-free DNA in this context is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
1. Sarcoidosis patients without evidence of active myocarditis:
* Inclusion:
* Diagnosis of sarcoidosis based on the ATS/ERS criteria.
* Normal 12 lead ECG within the past one year.
* Non-smoker.
* No immunosuppressive therapy for at least one year.
* Exclusion:
* Known cardiac disease.
* Active smoker.
* On immunosuppressive therapy.
2. Sarcoidosis patients with evidence of active myocarditis:
* Inclusion:
* Diagnosis of sarcoidosis based on the ATS/ERS criteria.
* Evidence of active myocarditis based on recent cMRI or cFDG-PET.
* Non-smoker.
* Exclusion:
* Known cardiac disease other than sarcoidosis.
* Active smoker.
* On immunosuppressive therapy.
3. Acute ST elevation myocardial infarction (STEMI):
* Inclusion:
* Diagnosis STEMI based on 1mm ST elevation in 2 or more contiguous leads.
* Symptom onset within 12 hours.
* Undergoing cardiac intervention for acute coronary syndrome.
* Able to consent for blood draw.
* Exclusion:
* Active smoker.
* Hemodynamically unstable.
4. Healthy controls:
* Inclusion:
* No known cardiac disease.
* No known cardiovascular risk factors: hypertension, diabetes.
* Non-smoker.
Where it's running
-
University of Iowa
Iowa City, Iowa, United States Recruiting -
University of Iowa
Iowa City, Iowa, United States Not yet recruiting
Study contacts
- Principal investigator: Nabeel Hamzeh, MD — University of Iowa
- Study coordinator: Brenda Werner, RN
- Email: brenda-r-werner@uiowa.edu
- Phone: 319-353-8862
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.