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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Composite Endpoint of All-Cause Death, Heart Transplantation, and Rehospitalization for Heart Failure [Срок оценки: End of months 1, 6, 12, 18, 24 and 36]

Вторичные конечные точки (1)

• All-cause death, heart transplant, heart failure rehospitalization, or sudden death [Срок оценки: End of months 1, 6, 12, 18, 24 and 36]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of S — Ухань

Идентификаторы

NCT: NCT06741995 · Jing yuan-DCM cohort study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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