A Real-world HCM-cohort Trial

NCT07638033 | Not Yet Recruiting DMC

• 1 other identifier: KY20262041-C-1
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy (HCM)

Outcome Measures

Primary Outcomes (1)

• MACE

  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.

  1, 6, 12, 24, 36, 60 months

Secondary Outcomes (15)

• Cardiac death

  1, 6, 12, 24, 36, 60 months

• Ischemic stroke

  1, 6, 12, 24, 36, 60 months

• Systemic embolism

  1, 6, 12, 24, 36, 60 months

• Malignant arrhythmia events

  1, 6, 12, 24, 36, 60 months

• Non-fatal myocardial infarction

  1, 6, 12, 24, 36, 60 months

Study Arms (1)

Hypertrophic cardiomyopathy

Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy.

Drug: Standard of care

Interventions

Standard of care DRUG

Standard of care

Hypertrophic cardiomyopathy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An expected enrollment of 3,000 HCM patients will be enrolled within the next 2 years.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

the First Affiliated Hospital of the Air Force Medical University

Xi'an, China/Shaan XI Province, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood samples will be collected at prespecified study time points. Whole blood will be processed to obtain plasma, serum, and buffy coat fractions. The buffy coat will be retained for genomic DNA extraction. Extracted DNA and residual plasma/serum samples will be stored in coded form for future analyses related to HCM mechanisms, biomarkers, and treatment response.

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ling Tao, MD, Ph.D

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Lanyan Guo, MD, Ph.D

CONTACT

+86-18189145929; guolany@163.com

Running Zhang, BSc

CONTACT

+86-15802990370; running-zhang@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)