Dilated Cardiomyopathy (DCM)NCT06741995
Evaluating the Prognostic Impact of Anti-β1AR Antibodies and Anti-L-CaC Antibodies in Patients With Dilated Cardiomyopathy
An observational study of Dilated Cardiomyopathy (DCM), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dilated Cardiomyopathy (DCM)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to 17 Dec 2027
- 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: Dilated cardiomyopathy (DCM) is a heterogeneous cardiomyopathy characterized by ventricular enlargement and reduced myocardial contractile function, with the exception of hypertension, heart valve disease, congenital heart disease, or ischemic heart disease at the onset. The clinical manifestations of dilated cardiomyopathy include progressive cardiac enlargement, reduced ventricular systolic function, heart failure, ventricular or supraventricular arrhythmias, conduction system abnormalities, thromboembolism, and sudden death.The etiology of DCM is complex and involves a variety of factors, including genetics, environment, and immunity.
Who may be able to join
- 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.
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
- 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.
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 Prognostic Impact of Anti-beta1AR Antibody and Anti-L-CaC Antibody 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.
- Conditions
- Dilated Cardiomyopathy (DCM)
- Medical subject headings
- Cardiomyopathy, Dilated
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint of All-Cause Death, Heart Transplantation, and Rehospitalization for Heart Failure
Measured: End of months 1, 6, 12, 18, 24 and 36
Secondary outcomes (1)
All-cause death, heart transplant, heart failure rehospitalization, or sudden death
Measured: End of months 1, 6, 12, 18, 24 and 36
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 completion17 Dec 2027 (estimated)
- Study completion17 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated Cardiomyopathy (DCM)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741995
- Sponsor's protocol ID
- Jing yuan-DCM cohort study
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 11 Apr 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 11 Apr 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 Prognostic Impact of Anti-beta1AR Antibody and Anti-L-CaC Antibody in Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06741995
- Acronym / sponsor ID
- Jing yuan-DCM cohort study
- Conditions
- Dilated Cardiomyopathy (DCM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 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
- 17 Dec 2027 (estimated)
- Study completion
- 17 Dec 2027 (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 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.
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
- Dilated cardiomyopathy (DCM) is a heterogeneous cardiomyopathy characterized by ventricular enlargement and reduced myocardial contractile function, with the exception of hypertension, heart valve disease, congenital heart disease, or ischemic heart disease at the onset. The clinical manifestations of dilated cardiomyopathy include progressive cardiac enlargement, reduced ventricular systolic function, heart failure, ventricular or supraventricular arrhythmias, conduction system abnormalities, thromboembolism, and sudden death.The etiology of DCM is complex and involves a variety of factors, including genetics, environment, and immunity.
Key inclusion criteria (3 listed)
- 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.
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
- 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
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
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
1 secondary outcome
All-cause death, heart transplant, heart failure rehospitalization, or sudden death
Time frame: End of months 1, 6, 12, 18, 24 and 36
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 11 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Dilated Cardiomyopathy (DCM)
RecruitingPhase 2/3
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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 Dilated Cardiomyopathy (DCM), 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 3 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 11 Apr 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?
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). 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 11 Apr 2025.