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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Dilated cardiomyopathy (DCM) is a heterogeneous cardiomyopathy characterized by ventricular enlargement and reduced myocardial contractile function, with the exception of hypertension, heart valve disease, congenital heart disease, or ischemic heart disease at the onset. The clinical manifestations of dilated cardiomyopathy include progressive cardiac enlargement, reduced ventricular systolic function, heart failure, ventricular or supraventricular arrhythmias, conduction system abnormalities, thromboembolism, and sudden death.The etiology of DCM is complex and involves a variety of factors, including genetics, environment, and immunity.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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 outcomes

1

All-cause death, heart transplant, heart failure rehospitalization, or sudden death

Time frame
End of months 1, 6, 12, 18, 24 and 36

Other outcomes

Sponsors and contacts

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