The China CardioMyopathy Registry Study

Not yet recruiting

• Conditions: Cardiomyopathies

• Registration Number: NCT05871632
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-13
• Last Update Submitted: 2023-05-13
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Study Start: 2023-07-01
• Primary Completion: 2025-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of participants with cardiovascular deaths	an average of 1 year	including sudden cardiac death and deaths due to heart failure and stroke

Secondary Outcome Measures

Name	Time	Method
number of participants with heart failure	an average of 1 year	progress to level III or IV in New York Heart Association class
number of participants with all-cause deaths	an average of 1 year	including deaths due to any causes
number of participants with myocardial infarction	an average of 1 year	including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction
number of participants with stroke	an average of 1 year	including cerebral infraction and hemorrhage

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China