Cell Free DNA in Cardiac Sarcoidosis

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Nabeel Hamzeh
Study ID
NCT03858777
Status
Recruiting
Apply to this trial

Conditions

  • Healthy
  • ST Elevation Myocardial Infarction
  • Sarcoidosis
  • Sarcoidosis With Myocarditis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • cell free DNA — DIAGNOSTIC_TEST
    All groups will have blood draws and cfDNA measured

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
Jan 2026
Primary completion
Dec 15, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Sarcoidosis patients without evidence of active myocarditis
    A single blood draw.
  • Experimental: Sarcoidosis patients with evidence of active myocarditis
    Two blood draws 2 months apart.
  • Active Comparator: Acute ST elevation myocardial infarction (STEMI)
    Three blood draws, baseline, 6 hours and 24 hours.
  • Placebo Comparator: Healthy controls
    A single blood draw

Primary Outcome Measure

cfDNA level [ Time Frame: 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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Brenda Werner, RN
[email protected]
319-353-8862
Nabeel Hamzeh, MD
[email protected]
319-356-8343
University of IowaIowa CityIowa52242
Brenda Werner, RN
[email protected]
319-353-8862

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IA

Related Studies