UIC Multi-Ethnic DCM Registry

NCT07145138 | Recruiting

• 1 other identifier: STUDY2023-0255
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Dilated cardiomyopathy (DCM), a condition where the heart loses its ability to pump blood throughout the body, is a common cause of death in the United States (US). It affects minorities more frequently and appears to causes greater harm than Whites. However, almost all research related to DCM has been performed in Whites, where up to half of cases run in the family. Several genes have been identified that cause the disease, but we are unsure if these same genes are also responsible for DCM in African Americans or Hispanic/Latino patients. The impact of various medical, social, and financial stressors on the severity of the disease in ethnic minorities also remains unclear. The investigators believe that certain genes are more common in different racial and ethnic groups and the greater medical, social, and financial burden faced by minorities in the US leads to more harm from DCM in these groups. The overall goal of the project is to test whether ethnic minority patients carrying genes that cause DCM experience more adverse effects in part because of various medical, social, and financial burdens. The investigators will first establish the UIC Multi-ethnic DCM Biorepository to look for how often certain genes are found across different race-ethnicity and then ask the question if these genes impact the severity of DCM. Finally, the investigators will study how a person's environment can alter the course of their disease. Through this, the investigators hope and strive to ensure equal and adequate heart care for individuals regardless of their race-ethnicity.

Conditions

Heart Failure; Dilated Cardiomyopathy (DCM)

Keywords

Dilated Cardiomyopathy; Heart Failure; Genomics; Social Determinants of Health; Variant

Outcome Measures

Primary Outcomes (1)

• Likely Pathogenic/Pathogenic Variants

  Utilizing genomic sequencing, the investigators will obtain blood samples at baseline for study participants and identify utilizing genomic sequencing the prevalence of likely pathogenic/pathogenic (LP/P) variants in dilated cardiomyopathy patients across race-ethnicity.

  Baseline

Secondary Outcomes (1)

• Severity of Disease Symptoms: Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score

  Participants with heart failure or who develop heart failure will complete the digital MLHFQ assessments at 12 months, 24 months, and 60 months after initial enrollment or new heart failure diagnosis.

Study Arms (2)

Dilated Cardiomyopathy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only nonpregnant and noninstitutionalized adults will be considered for study enrollment. Two separate groups of patients will be eligible for study enrollment, those without a history of DCM (i.e. controls) and those with an identified history of DCM (i.e. cases). Clinic lists, inpatient team lists, and echocardiography lab lists will be surveyed daily by study coordinators to identify potential enrollees. Subjects will be approached for potential enrollment during outpatient visits to either the Family Medicine clinics, Internal Medicine clinics, or one of the four outpatient Cardiology Clinic or during inpatient stay at University of Illinois Hospital. Patients will be categorized as having DCM based on clinically report history or a transthoracic echocardiography (TTE) or cardiac magnetic resonance imaging (CMRI) showing LVEF \<50% and LV end-diastolic diameter (LVEDD) ≥95th percentile, meeting criteria for DCM.

You may qualify if:

• Must be at least 18 years of age and be admitted to or seen at a UIH site.
• Subjects must be willing and able to give written, informed consent

You may not qualify if:

• Adults who are unable to provide consent
• Women who are pregnant at the baseline visit,
• Prisoners
• Individuals who are not yet adults (infants, children, teenagers).

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Hospital & Health Sciences

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

David Tofovic, M.D.

CONTACT

312-355-7111; dtofov2@uic.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: August 28, 2025
• Study Start: July 11, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2038
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)