A Real-world HCM-cohort Trial
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
- The protocol lists: Standard of care.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy (HCM). Basic parameters: No limits · 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 →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Prospective, Real-world Study on Hypertrophic Cardiomyopathy
Overview
Hypertrophic cardiomyopathy (HCM) is a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy. Patients with HCM commonly present with dyspnea, chest pain, and exercise intolerance. Sudden cardiac death, progressive heart failure, and thromboembolic events remain the leading causes of mortality and morbidity, substantially impairing quality of life and increasing healthcare burden. Despite advances in understanding the pathophysiology, diagnosis, and management of HCM, significant challenges persist, including etiological heterogeneity and underdiagnosis. At present, dedicated and systematic HCM databases remain lacking in China. Establishing a nationally HCM cohort and disease-specific database is therefore of considerable importance. In alignment with the goals of the "Healthy China 2030" initiative and supported by advances in medical big data technologies. This study aims to construct a comprehensive HCM cohort, evaluate contemporary diagnostic and therapeutic practices and patient prognosis, identify relevant risk factors, and ultimately improve the overall management of patients with HCM.
Interventions
- Drug Standard of care
Standard of care
Primary outcome measures
- MACE [Time frame: 1, 6, 12, 24, 36, 60 months]
Secondary outcome measures (12)
- Cardiac death [Time frame: 1, 6, 12, 24, 36, 60 months]
- Ischemic stroke [Time frame: 1, 6, 12, 24, 36, 60 months]
- Systemic embolism [Time frame: 1, 6, 12, 24, 36, 60 months]
- Malignant arrhythmia events [Time frame: 1, 6, 12, 24, 36, 60 months]
- Non-fatal myocardial infarction [Time frame: 1, 6, 12, 24, 36, 60 months]
- Rehospitalization for heart failure. [Time frame: 1, 6, 12, 24, 36, 60 months]
- All-cause mortality [Time frame: 1, 6, 12, 24, 36, 60 months]
- Number of rehospitalizations for heart failure [Time frame: 1, 6, 12, 24, 36, 60 months]
- New-onset atrial arrhythmias [Time frame: 1, 6, 12, 24, 36, 60 months]
- End-stage heart failure [Time frame: 1, 6, 12, 24, 36, 60 months]
- Heart transplantation [Time frame: 1, 6, 12, 24, 36, 60 months]
- Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy [Time frame: 1, 6, 12, 24, 36, 60 months]
Eligibility criteria
Inclusion criteria
- Meet the clinical diagnostic criteria for HCM\*;
- Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form, have good compliance, and are willing to undergo clinical follow-up.
- Clinical diagnosis of HCM is defined as left ventricular wall thickness ≥15mm at any position during diastole by.echocardiography or CMR (≥13mm if there is a family history of HCM or positive cardiac genetic testing), and other secondary factors (such as severe hepertension, aortic stenosis) causing myocardial hypertrophy are excluded.
Exclusion criteria
- Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;
- Severe systemic hypertension and/or severe aortic stenosis (<1cm²);
- Comorbid malignant tumors;
- Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;
- Comorbid with mental disorders;
- Currently participating in other clinical trials and not reaching the primary endpoint.
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
- the First Affiliated Hospital of the Air Force Medical University — Xi'an
Identifiers
NCT: NCT07638033 · KY20262041-C-1