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NCT Number: NCT06741995

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

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.

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Key information

Conditions

Dilated Cardiomyopathy (DCM) Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Wei Liang, Doctor

CONTACT

[email protected]

86-13407127102

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Yuan

CONTACT

[email protected]

86-13886121012

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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