Viral MyocarditisNCT06742008
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
An observational study of Viral Myocarditis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Viral Myocarditis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Meets diagnostic criteria for VMC
- Clinical symptoms present for no more than 30 days
- Age ≥ 18 years and ≤ 75 years
- Subjects or their legal guardians are fully informed of the nature and risks of the study, participate voluntarily, and sign an informed consent form.
Who cannot join
- 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
- Systemic autoimmune disease such as systemic lupus erythematosus or diagnosed immunodeficiency disease at enrollment
- Pregnancy or breastfeeding
- Combination of serious diseases affecting survival, such as tumors, with a life expectancy shorter than 3 months
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China
Wuhan, Hubei, 430000
Wei Liang, Doctor, 86-13407127102, liangwei_kimi@163.com
About this study
Official title: 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.
- Conditions
- Viral Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of evolution to DCM in patients positive for anti-β1AR antibodies and anti-L-CaC antibodies
Measured: End of months 1, 3 and 6
Secondary outcomes (1)
All-Cause Death, Rehospitalization for Heart Failure, or Sudden Death in Patients Positive for Anti-β1AR Antibodies and Anti-L-CaC Antibodies
Measured: End of months 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start17 Dec 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral MyocarditisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742008
- Sponsor's protocol ID
- Jing yuan-VMC cohort study
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06742008
- Acronym / sponsor ID
- Jing yuan-VMC cohort study
- Conditions
- Viral Myocarditis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Meets diagnostic criteria for VMC
- Clinical symptoms present for no more than 30 days
- Age ≥ 18 years and ≤ 75 years
- Subjects or their legal guardians are fully informed of the nature and risks of the study, participate voluntarily, and sign an informed consent form.
Key exclusion criteria (7 listed)
- 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
- Systemic autoimmune disease such as systemic lupus erythematosus or diagnosed immunodeficiency disease at enrollment
- Pregnancy or breastfeeding
- Combination of serious diseases affecting survival, such as tumors, with a life expectancy shorter than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Myocarditis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Yuan (86-13886121012, yhelen13@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.