NCT04837612

Observational Study for Patients With Dilated Cardiomyopathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Observational study on patients with dilated cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis of patients with dilated cardiomyopathy, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of dilated cardiomyopathy. Therefore, endpoints indluding all-cause mortality, cardiovascular death, ventricular arrythmia, non-fatal stroke, non-fatal myocardial infarction, sudden death, successful cardiopulmonary resuscitation will be evaluated.

Detailed description

In this observational study on patients with dilated cardiomyopathy, 500 eligible patients, who were diagnosed as dilated cardiomyopathy by echocardiography, will be recruited with a median follow up of 5 years.Patients will be excluded who develop cardiac enlargement caused by other factors such as myocardial ischemia, myocarditis, diabetic cardiomyopathy, valvular heart disease, congenital heart disease; who had underwent heart transplatation; who are not suitable for the present study due to maligant tumor or severe trauma. Eligible individuals, identified based on echocardiography and medical records, were invited to a community clinic by phone. For eligible individuals, study data were comprised of a self-administered questionnaire, anthropometric features, laboratory examinations, echocardiographic and/or cardiac magetic resnonance data. Anthropometric data were measured by experienced research staff in the morning under standardized conditions. Echocardiographic measuring were performed by three skilled sonographers independently, based on routine protocols on an HP5500 (Phillips Medical System, Boston, Massachusetts, USA) per current guidelines. Venous blood samples were collected in the morning following overnight fasting. Laboratory procedures were performed under standardized conditions. Endpoints including all-cause mortality, cardiovascular death, sudden death (ICD-Code I46.1, R96), ventricular tachycardia(ICD-code I47.2)/fibrillation/flutter(ICD-code I49.0), hospitalization for heart failure(ICD-Code I50), heart transplatation ((ICD-Code Z94.1), non-fatal stroke(ICD-Code I60, I61, I63, I64), non-fatal myocardial infarction (ICD-Code I21), sudden death (ICD-Code I46.1, R96), successful cardiopulmonary resuscitation (ICD-Code I46.0) will be evaulated. Across the whole observational study, 50 endpoints are anticipated to occur annually, and therefore the sample size was estimated to be approximately 500 subjects. Data collection and management will be conducted via electronic data collection (EDC). Source data will be checked regularly to assess the accuracy and completeness. For statistical analysis, continuous variables are presented as mean±standard deviation (SD), and compared by the Student t-test. Categorical variables are presented as frequency and assessed by the χ2 test. SAS 9.4 for Windows (release 6.11, USA) is to be utilized for statistical analysis.

Conditions

• DCM - Dilated Cardiomyopathy

Interventions

Type	Name	Description
OTHER	No intervention nor exposure	As an observational study, no intervention nor exposure is interested.

Timeline

• Start date: 2019-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: China