Recruiting

cfDNA Analysis

Sponsor:

Nabeel Hamzeh

Code:

NCT03858777

Conditions

Sarcoidosis With Myocarditis

Sarcoidosis

Healthy

ST Elevation Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

cell free DNA

Study Details

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.

Conditions

Sarcoidosis With Myocarditis

Sarcoidosis

Healthy

ST Elevation Myocardial Infarction

Study ID

NCT03858777

Start date

May 1, 2019

Status verified date

Jan, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

cell free DNA

All groups will have blood draws and cfDNA measured

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 and Locations

Central contacts

Brenda Werner, RN

319-353-8862brenda-r-werner@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Brenda Werner, RN

319-353-8862brenda-r-werner@uiowa.edu

More Information

Sponsor

Nabeel Hamzeh

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • sarcoidosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nabeel Hamzeh on 2026-01-09.