Heart FailureNCT07145138
UIC Multi-Ethnic DCM Registry
An observational study of Heart Failure and Dilated Cardiomyopathy (DCM), run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Dilated Cardiomyopathy (DCM)
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Hospital & Health Sciences
Chicago, Illinois, 60612
Yining Chen, M.S., 312-355-1861, yining@uic.edu
About this study
Official title: 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.
- Conditions
- Heart Failure, Dilated Cardiomyopathy (DCM)
- Keywords
- Dilated Cardiomyopathy, Heart Failure, Genomics, Social Determinants of Health, Variant
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dilated Cardiomyopathy | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Severity of Disease Symptoms: Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start11 Jul 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Tofovic, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145138
- Sponsor's protocol ID
- STUDY2023-0255
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Illinois Chicago (UIC) Multi-Ethnic Dilated Cardiomyopathy (DCM) Registry
- ClinicalTrials.gov ID
- NCT07145138
- Acronym / sponsor ID
- STUDY2023-0255
- Conditions
- Heart Failure, Dilated Cardiomyopathy (DCM)
- Keywords
- Dilated Cardiomyopathy, Heart Failure, Genomics, Social Determinants of Health, Variant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilated Cardiomyopathy | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Dilated Cardiomyopathy (DCM), run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Tofovic, M.D. (312-355-7111, dtofov2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likely Pathogenic/Pathogenic Variants (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.