Cell Free DNA in Cardiac Sarcoidosis
cfDNA in CS
Cardiomyocyte Specific Cell Free DNA as a Marker of Cardiac Sarcoidosis
1 other identifier
interventional
120
1 country
2
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 function. In addition, IST can suppress arrhythmias that develop due to active myocarditis and prevent the formation of scar. The potential role of cardiac biomarkers, including brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), and cardiac troponins, in detecting active myocarditis is limited and studies have been disappointing. At present, there are no biomarkers to detect active myocarditis and the use of advanced imaging modalities (FDG-PET) for assessing and monitoring active myocarditis is not feasible or practical and is associate with high radiation exposure. As such, a biomarker that is reflective of active myocarditis and that is cardiac specific will assist physicians in assessing the presence of active myocarditis to guide therapeutic decisions and to assess response to therapy which can limit further cardiac damage. Cell free DNA (cfDNA) are fragments of genomic DNA that are released into the circulation from dying or damaged cells. It is a powerful diagnostic tool in cancer, transplant rejection and fetal medicine especially when the genomic source differs from the host. A novel technique that relies on tissue unique CpG methylation patterns can identify the tissue source of cell free DNA in an individual reflecting potential tissue injury. We will be conducting a pilot study to explore the utility of this diagnostic tool to identify granulomatous myocarditis in patients with sarcoidosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
January 9, 2026
January 1, 2026
8.6 years
February 25, 2019
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (4)
Sarcoidosis patients without evidence of active myocarditis
ACTIVE COMPARATORA single blood draw.
Sarcoidosis patients with evidence of active myocarditis
EXPERIMENTALTwo blood draws 2 months apart.
Acute ST elevation myocardial infarction (STEMI)
ACTIVE COMPARATORThree blood draws, baseline, 6 hours and 24 hours.
Healthy controls
PLACEBO COMPARATORA single blood draw
Interventions
All groups will have blood draws and cfDNA measured
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known cardiac disease.
- Active smoker.
- On immunosuppressive therapy.
- Sarcoidosis patients with evidence of active myocarditis:
- Diagnosis of sarcoidosis based on the ATS/ERS criteria.
- Evidence of active myocarditis based on recent cMRI or cFDG-PET.
- Non-smoker.
- Known cardiac disease other than sarcoidosis.
- Active smoker.
- On immunosuppressive therapy.
- Acute ST elevation myocardial infarction (STEMI):
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nabeel Hamzehlead
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
University of Iowa
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nabeel Hamzeh, MD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 25, 2019
First Posted
March 1, 2019
Study Start
May 1, 2019
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share