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

Not yet recruiting

• Conditions: Dilated Cardiomyopathy (DCM)

• Registration Number: NCT06741995
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-15
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2028-12-15
• Study Completion: 2028-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Endpoint of All-Cause Death, Heart Transplantation, and Rehospitalization for Heart Failure	End of months 1, 6, 12, 18, 24 and 36

Secondary Outcome Measures

Name	Time	Method
All-cause death, heart transplant, heart failure rehospitalization, or sudden death	End of months 1, 6, 12, 18, 24 and 36