Evaluating antibodies in patients with viral myocarditis and their risk of heart disease
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
This study is testing whether certain antibodies in patients with viral myocarditis can help predict their risk of developing serious heart problems later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06742008 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive value of anti-beta1AR and anti-L-CaC antibodies in patients diagnosed with acute viral myocarditis (AVMC). It focuses on understanding how these antibodies may influence the progression from AVMC to dilated cardiomyopathy (DCM), a serious heart condition. By monitoring antibody levels, the study seeks to provide insights into patient prognosis and potential risks associated with the autoimmune response to viral infections. Participants will be monitored for clinical symptoms and antibody levels over a specified period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have been diagnosed with acute viral myocarditis and have clinical symptoms present for no more than 30 days.
Not a fit: Patients with serious uncontrolled infections, systemic autoimmune diseases, or other severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk of developing dilated cardiomyopathy, allowing for earlier intervention and improved management.
How similar studies have performed: While the specific role of anti-L-CaC antibodies is not well-established, previous studies have indicated that monitoring anti-beta1AR antibodies may provide valuable prognostic information in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Jing Yuan
- Email: yhelen13@163.com
- Phone: 86-13886121012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.