NCT03858777: cfDNA in CS

Cell Free DNA in Cardiac Sarcoidosis

Recruiting now NA Last updated 9 January 2026

What this trial tests

NA trial testing cell free DNA in Sarcoidosis With Myocarditis in 120 participants. Currently enrolling.

Timeline

1 May 2019

Primary endpoint
15 December 2027

30 June 2028

Quick facts

Lead sponsor	Nabeel Hamzeh
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	120
Start date	1 May 2019
Primary completion	15 December 2027
Estimated completion	30 June 2028
Sites	2 locations across United States

Drugs / interventions tested

• cell free DNA

Conditions studied

• Sarcoidosis With Myocarditis — all drugs for Sarcoidosis With Myocarditis →
• Sarcoidosis — all drugs for Sarcoidosis →
• Healthy — all drugs for Healthy →
• ST Elevation Myocardial Infarction — all drugs for ST Elevation Myocardial Infarction →

Sponsor

Nabeel Hamzeh

Who can join

18 and older, any sex, with Sarcoidosis With Myocarditis or Sarcoidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current Trends in Cell-Free DNA Applications. Scoping Review of Clinical Trials.
   Stawski R, Stec-Martyna E, Chmielecki A, Nowak D, et al · · 2021 · cited 20× · PMID 34571783 · DOI 10.3390/biology10090906