Evaluating the impact of specific antibodies in patients with dilated cardiomyopathy
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
This study is trying to see if certain antibodies in people with dilated cardiomyopathy can help predict their heart health and outcomes over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (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 | NCT06741995 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prognostic significance of anti-β1AR and anti-L-CaC antibodies in patients diagnosed with dilated cardiomyopathy (DCM). Conducted as a multicenter, prospective cohort study in China, it will follow DCM patients over a period of three years to evaluate the relationship between these antibodies and clinical outcomes such as cardiovascular death and ventricular tachycardia. The study seeks to provide valuable epidemiological data and identify potential therapeutic targets for DCM management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who have been diagnosed with dilated cardiomyopathy.
Not a fit: Patients with serious uncontrolled infections, active bleeding, or other severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the prognostic evaluation and treatment strategies for patients with dilated cardiomyopathy.
How similar studies have performed: Previous studies have suggested associations between these antibodies and adverse outcomes in DCM, but this study aims to provide more robust multicenter data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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.
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.