Assessment of the Predictive Value of Anti-beta1AR and Anti-L-CaC Antibodies in the Evolution to Dilated Cardiomyopathy in Patients With Acute Viral Myocarditis

December 11, 2025 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

DCM Anti-Heart Antibody Diagnostic Kit Study--assessment of the Predictive Value of Anti-beta1AR and Anti-L-CaC Antibodies in the Evolution to Dilated Cardiomyopathy in Patients With Acute Viral Myocarditis

Background of the study Studies have shown that about one-third of patients with acute viral myocarditis (AVMC) eventually develop dilated cardiomyopathy (DCM), and that the autoimmune response to viral infection is key to the development of AVMC to DCM. A variety of antimyocardial autoantibodies (AHAs) are detected in the sera of patients with myocarditis. Among them, anti-β1AR antibodies are thought to contribute to the transition of AVMC to DCM possibly by promoting myocardial injury, cardiac remodeling, and impaired cardiac function. The role of anti-L-CaC antibodies in the evolution of AVMC to DCM is unknown, but they have been shown to induce ventricular tachycardia by increasing calcium inward flow and triggering early afterdepolarization, increasing the rate of sudden death and all-cause mortality in patients. Therefore, monitoring the levels of these antibodies may be useful in assessing the prognosis of patients with viral myocarditis. In this study, we propose to use a multicenter, prospective cohort study to further accurately assess the predictive value of these autoantibodies in the evolution of AVMC patients to DCM by detecting the serum levels of anti-β1AR antibodies and anti-L-CaC antibodies in AVMC patients and combining them with the clinical data and follow-up data, so as to provide prognostic biomarkers as well as targets for targeted interventions in AVMC.

Objective of the study A multicenter, prospective cohort study of the value of anti-β1AR and anti-L-CaC antibodies in the progression of AVMC patients to DCM, enrolling 300 AVMC patients, to further accurately assess the predictive value of anti-β1AR and anti-L-CaC antibodies in the progression of AVMC patients to DCM, and provide prognostic biomarkers and targeted interventions for AVMC. The study will provide prognostic biomarkers and targeted intervention for AVMC.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Viral myocarditis (VMC) is an inflammation of the myocardium caused by viral infections. Common viruses include coxsackievirus, adenovirus, cytomegalovirus, and influenza virus. The prognosis for patients with Acute viral myocarditis (AVMC) varies widely, with most patients recovering with treatment, but some progressing to dilated cardiomyopathy (DCM). Studies have shown that about one-third of patients with AVMC eventually develop DCM, and that the immune response following viral infection is key to the development of DCM in AVMC. Following viral infection, specific antigenic determinants within cardiomyocytes are exposed to the immune system, triggering an autoimmune response against the myocardium, leading to damage and dysfunction of cardiomyocytes.

Description

Inclusion Criteria:

  1. Meets diagnostic criteria for VMC
  2. Clinical symptoms present for no more than 30 days
  3. Age ≥ 18 years and ≤ 75 years
  4. 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:

  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. Systemic autoimmune disease such as systemic lupus erythematosus or diagnosed immunodeficiency disease at enrollment
  4. Pregnancy or breastfeeding
  5. Combination of serious diseases affecting survival, such as tumors, with a life expectancy shorter than 3 months
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of evolution to DCM in patients positive for anti-β1AR antibodies and anti-L-CaC antibodies
Time Frame: End of months 1, 3 and 6
End of months 1, 3 and 6

Secondary Outcome Measures

Outcome Measure
Time Frame
All-Cause Death, Rehospitalization for Heart Failure, or Sudden Death in Patients Positive for Anti-β1AR Antibodies and Anti-L-CaC Antibodies
Time Frame: End of months 1, 3 and 6
End of months 1, 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jing yuan-VMC cohort study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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