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NCT Number: NCT05871632

The China CardioMyopathy Registry Study

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. number of participants with cardiovascular deaths

    Time frame: an average of 1 year

    including sudden cardiac death and deaths due to heart failure and stroke

Secondary outcomes

  1. number of participants with heart failure

    Time frame: an average of 1 year

    progress to level III or IV in New York Heart Association class

  2. number of participants with stroke

    Time frame: an average of 1 year

    including cerebral infraction and hemorrhage

  3. number of participants with myocardial infarction

    Time frame: an average of 1 year

    including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction

  4. number of participants with all-cause deaths

    Time frame: an average of 1 year

    including deaths due to any causes

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Song, MD.&phD

CONTACT

[email protected]

86-13810532620

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: CHINA-CM

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 23, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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