Evaluating the Prognostic Impact of Anti-β1AR Antibodies and Anti-L-CaC Antibodies in Patients With Dilated Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dilated Cardiomyopathy (DCM). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Composite Endpoint of All-Cause Death, Heart Transplantation, and Rehospitalization for Heart Failure [Time frame: End of months 1, 6, 12, 18, 24 and 36]
Secondary outcome measures (1)
- All-cause death, heart transplant, heart failure rehospitalization, or sudden death [Time frame: End of months 1, 6, 12, 18, 24 and 36]
Eligibility criteria
Inclusion criteria
- Age 18-75, any gender
- Diagnosed with dilated cardiomyopathy
- 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
- Serious uncontrolled infection at enrolment ("uncontrolled" is defined as signs and symptoms of infection that persist without improvement despite antimicrobial or other treatment)
- Uncontrolled active bleeding at enrollment
- Pregnancy or breastfeeding
- Combination of serious diseases affecting survival, such as tumors, with a life expectancy of less than one year
- Previous heart transplant or implantation of a cardiac assist device
- Patients with poor compliance who are unable to complete the full course of the study
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of S — Wuhan
Identifiers
NCT: NCT06741995 · Jing yuan-DCM cohort study