The China CardioMyopathy Registry Study

Cardiomyopathies Clinical Trial

— CHINA-CM  

Official title:

The China CardioMyopathy Registry Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05871632
• Other study ID #: CHINA-CM
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Lei Song, MD.&phD
• Phone: 86-13810532620
• Email: clinicalfw[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, so it has a huge psychological and economic burden on family members. Studying the clinical characteristics of patients with cardiomyopathy is helpful for further diagnosis, treatment and management, which has important clinical and social significance.

Description:

In this study, patients hospitalized with cardiomyopathy as the primary discharge diagnosis in China are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. Data are collected with the use of case report forms (CRFs) and are entered into a web-based system. A 6 mL venous blood sample is obtained from consenting patients. Each participant is scheduled to be followed up by telephone every 12 months after admission to hospital.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.

Exclusion Criteria:

• Patients who refuse to sign the informed consent or decline follow-up.

Related Conditions & MeSH terms

• Cardiomyopathies

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with cardiovascular deaths	including sudden cardiac death and deaths due to heart failure and stroke	an average of 1 year
Secondary	number of participants with heart failure	progress to level III or IV in New York Heart Association class	an average of 1 year
Secondary	number of participants with stroke	including cerebral infraction and hemorrhage	an average of 1 year
Secondary	number of participants with myocardial infarction	including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction	an average of 1 year
Secondary	number of participants with all-cause deaths	including deaths due to any causes	an average of 1 year