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Evaluating the Prognostic Impact of Anti-β1AR Antibodies and Anti-L-CaC Antibodies in Patients With Dilated Cardiomyopathy

DCM Anti-Heart Antibody Diagnostic Kit Study--assessment of the Prognostic Impact of Anti-beta1AR Antibody and Anti-L-CaC Antibody in Patients With Dilated Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06741995
Enrollment
1000
Registered
2024-12-19
Start date
2024-12-17
Completion date
2027-12-17
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy (DCM)

Brief summary

Background of the study The etiology of dilated cardiomyopathy (DCM) is complex and involves a variety of genetic, environmental, and immunologic factors. Autoimmune reactions (especially anti-cardiac autoantibodies) play an important role in the development of DCM. In recent years, several clinical studies have suggested that anti-β1AR and anti-L-CaC antibodies are associated with cardiovascular death, ventricular tachycardia, and sudden death in patients with DCM, which is of great value in the prognostic evaluation of DCM. However, most of these studies are single-center studies with small sample sizes and non-uniform testing methods. In this study, we will use a multicenter, prospective cohort study to follow up DCM patients in China for a period of 3 years, to further accurately assess the clinical predictive value of anti-β1AR antibody and anti-L-CaC antibody on the prognosis of DCM patients, and to provide epidemiological information as well as targeted therapeutic targets for DCM. Aims of the study A multicenter, prospective cohort study of anti-β1AR and anti-L-CaC antibodies for prognostic assessment of DCM patients, enrolling 1,000 DCM patients, to further accurately assess the prognostic value of the anti-AHA assay for DCM patients, and to provide targets for targeted treatment of DCM.

Interventions

None listed

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-75, any gender 2. Diagnosed with dilated cardiomyopathy 3. Subjects or their legal guardians are fully informed of the nature and risks of the study, participate voluntarily, and sign an informed consent form.

Exclusion criteria

1. Serious uncontrolled infection at enrolment (uncontrolled is defined as signs and symptoms of infection that persist without improvement despite antimicrobial or other treatment) 2. Uncontrolled active bleeding at enrollment 3. Pregnancy or breastfeeding 4. Combination of serious diseases affecting survival, such as tumors, with a life expectancy of less than one year 5. Previous heart transplant or implantation of a cardiac assist device 6. Patients with poor compliance who are unable to complete the full course of the study 7. Other conditions (e.g., overstimulation, sensitivity, cognitive impairment, mental illness, or substance abuse/addiction) that, in the judgment of the investigator, may increase the risk to the subject or interfere with the clinical study and judgment of the results.

Design outcomes

Primary

MeasureTime frame
Composite Endpoint of All-Cause Death, Heart Transplantation, and Rehospitalization for Heart FailureEnd of months 1, 6, 12, 18, 24 and 36

Secondary

MeasureTime frame
All-cause death, heart transplant, heart failure rehospitalization, or sudden deathEnd of months 1, 6, 12, 18, 24 and 36

Countries

China

Contacts

Primary ContactJing Yuan
yhelen13@163.com86-13886121012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026