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NCT03858777 · ClinicalTrials.gov registry record · NA
Cell Free DNA in Cardiac Sarcoidosis
A NA study of Healthy and Sarcoidosis, sponsored by Nabeel Hamzeh.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT03858777 is a NA study of Healthy and Sarcoidosis that is actively recruiting participants, run by Nabeel Hamzeh. The registered enrollment target is 120 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03858777, a NA study of Healthy and Sarcoidosis, is actively recruiting participants, sponsored by Nabeel Hamzeh.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST cell free DNA
Study Locations (2)
Iowa
- University of Iowa - Iowa City
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03858777
The ClinicalTrials.gov registry entry for NCT03858777 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower). The listed sponsor is Nabeel Hamzeh, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which cell free DNA is the first listed.
NCT03858777 reports 2 study locations spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT03858777 about?
NCT03858777 is a clinical study titled "Cell Free DNA in Cardiac Sarcoidosis". 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 b...
What is the current status of trial NCT03858777?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2019-05-01. Estimated completion is 2028-06-30.
What conditions does trial NCT03858777 study?
This clinical trial studies the following conditions: Healthy, Sarcoidosis, ST Elevation Myocardial Infarction, Sarcoidosis With Myocarditis.
What interventions are being tested in trial NCT03858777?
The interventions under investigation include: cell free DNA (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03858777?
This trial is sponsored by Nabeel Hamzeh, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03858777 being conducted?
This trial has 2 study locations across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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