UIC Multi-Ethnic DCM Registry

August 20, 2025 updated by: David Tofovic, University of Illinois at Chicago

University of Illinois Chicago (UIC) Multi-Ethnic Dilated Cardiomyopathy (DCM) Registry

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: David Tofovic, M.D.
  • Phone Number: 312-355-7111
  • Email: dtofov2@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital & Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Control
Dilated Cardiomyopathy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Likely Pathogenic/Pathogenic Variants
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of Disease Symptoms: Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Time Frame: 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.
Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score will be administered to study participants with heart failure at set time points to access symptom burden. Score is based on a range of 0 to 105, with lower scores corresponding to lower symptom burden.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY2023-0255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research within the University of Illinois Chicago (UIC) and outside (non-UIC) interrogators in the future for research purposes only. These requests will be subject to IRB approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA) at UIC and any outside institution.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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