Menu
Not yet recruiting NCT05871632

The China CardioMyopathy Registry Study

Observational Cardiomyopathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiomyopathies. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • number of participants with cardiovascular deaths [Time frame: an average of 1 year]
Secondary outcome measures (4)
  • number of participants with heart failure [Time frame: an average of 1 year]
  • number of participants with stroke [Time frame: an average of 1 year]
  • number of participants with myocardial infarction [Time frame: an average of 1 year]
  • number of participants with all-cause deaths [Time frame: an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fuwai hospital — Beijing

Identifiers

NCT: NCT05871632 · CHINA-CM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗