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Clinical Trial NCT03858777 (cfDNA in CS) for Sarcoidosis With Myocarditis, Sarcoidosis, Healthy, ST Elevation Myocardial Infarction is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cell Free DNA in Cardiac Sarcoidosis (cfDNA in CS) 120 Biomarker-Driven Novel Treatment

Recruiting
Clinical Trial NCT03858777 (cfDNA in CS) is an interventional study for Sarcoidosis With Myocarditis, Sarcoidosis, Healthy, ST Elevation Myocardial Infarction that is recruiting. It started on 1 May 2019 with plans to enroll 120 participants. Led by Nabeel Hamzeh, it is expected to complete by 30 June 2028. The latest data from ClinicalTrials.gov was last updated on 9 January 2026.
Brief Summary
Sarcoidosis is a multisystem granulomatous disease of unknown cause that can affect any organ in the body, including the heart. Granulomatous myocarditis can lead to ventricular dysfunction and ventricular arrhythmias causing significant morbidity and mortality. Immunosuppressive therapy (IST) has been shown to reverse active myocarditis and preserve left ventricular (LV) function and in some cases improve LV functio...Show More
Detailed Description
Sarcoidosis is a multisystem granulomatous disease of unknown cause that can affect any organ in the body, including the heart. Sarcoidosis results from an immune reaction to an environmental exposure to yet unknown antigen(s) in a genetically predisposed individual. Autopsy studies have suggested that cardiac involvement with sarcoidosis occurs in up to 25% of cases, although more than half of these cases are sub-cl...Show More
Official Title

Cardiomyocyte Specific Cell Free DNA as a Marker of Cardiac Sarcoidosis

Conditions
Sarcoidosis With MyocarditisSarcoidosisHealthyST Elevation Myocardial Infarction
Other Study IDs
  • cfDNA in CS
  • 201812737
NCT ID Number
NCT03858777
Start Date (Actual)
2019-05-01
Last Update Posted
2026-01-09
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
sarcoidosis
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorSarcoidosis patients without evidence of active myocarditis
A single blood draw.
cell free DNA
All groups will have blood draws and cfDNA measured
ExperimentalSarcoidosis patients with evidence of active myocarditis
Two blood draws 2 months apart.
cell free DNA
All groups will have blood draws and cfDNA measured
Active ComparatorAcute ST elevation myocardial infarction (STEMI)
Three blood draws, baseline, 6 hours and 24 hours.
cell free DNA
All groups will have blood draws and cfDNA measured
Placebo ComparatorHealthy controls
A single blood draw
cell free DNA
All groups will have blood draws and cfDNA measured
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
cfDNA level
cfDNA level
cfDNA level at baseline and 2 months for sarcoidosis with heart disease compared to cfDNA levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfDNA levels at baseline, 6 and 24 hours for STEMI patients.
Participation Assistant
Eligibility 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.
Nabeel Hamzeh logoNabeel Hamzeh
Study Responsible Party
Nabeel Hamzeh, Sponsor-Investigator, Associate Professor of Medicine, University of Iowa
Study Central Contact
Contact: Brenda Werner, RN, 319-353-8862, [email protected]
2 Study Locations in 1 Countries

Iowa

University of Iowa, Iowa City, Iowa, 52242, United States
Brenda Werner, RN, Contact, 319-353-8862, [email protected]
Nabeel Hamzeh, MD, Contact, 319-356-8343, [email protected]
Not yet recruiting
University of Iowa, Iowa City, Iowa, 52242, United States
Brenda Werner, RN, Contact, 319-353-8862, [email protected]
Recruiting