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NCT Number: NCT07638033

A Real-world HCM-cohort Trial

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of the Air Force Medical University

Xi'an, China/Shaan XI Province, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Standard of care

Drug

Standard of care

Primary outcomes

  1. MACE

    Time frame: 1, 6, 12, 24, 36, 60 months

    The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiac death, ischemic stroke, systemic embolism, malignant arrhythmia events, non-fatal myocardial infarction, and rehospitalization for heart failure.

Secondary outcomes

  1. Cardiac death

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of individual components of MACE.

  2. Ischemic stroke

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of individual components of MACE.

  3. Systemic embolism

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of individual components of MACE.

  4. Malignant arrhythmia events

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of individual components of MACE.

  5. Non-fatal myocardial infarction

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of individual components of MACE.

  6. Rehospitalization for heart failure.

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of individual components of MACE.

  7. All-cause mortality

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of all-cause mortality.

  8. Number of rehospitalizations for heart failure

    Time frame: 1, 6, 12, 24, 36, 60 months

    Total number of rehospitalizations for heart failure during follow-up.

  9. New-onset atrial arrhythmias

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of new-onset atrial arrhythmias, including atrial tachycardia, atrial flutter, and atrial fibrillation.

  10. End-stage heart failure

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of end-stage heart failure.

  11. Heart transplantation

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of heart transplantation.

  12. Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy.

  13. Anxiety/depressive mental disorders

    Time frame: 1, 6, 12, 24, 36, 60 months

    Incidence of anxiety/depressive mental disorders.

  14. The Kansas City Cardiomyopathy Questionnaire (KCCQ) ≥5-point improvement

    Time frame: 1, 6, 12, 24, 36, 60 months

    Proportion of patients achieving a ≥5-point improvement in KCCQ score from baseline after treatment. The KCCQ Overall Summary Score ranges from 0 to 100, with higher scores indicating better health status.A ≥5-point increase is considered a clinically meaningful improvement.

  15. BARC 3 or 5 bleeding

    Time frame: [1, 6, 12, 24, 36, 60 months]

    Incidence of BARC 3 or 5 bleeding.

Study contacts

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

Lanyan Guo, MD, Ph.D

CONTACT

[email protected]

+86-18189145929

Running Zhang, BSc

CONTACT

[email protected]

+86-15802990370

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

A Multicenter, Prospective, Real-world Study on Hypertrophic Cardiomyopathy

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

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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