A Real-world HCM-cohort Trial

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertrophic Cardiomyopathy (HCM)
• Intervention / Treatment: Drug: Standard of care

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Running Zhang, BSc; Phone Number: +86-15802990370; Email: running-zhang@qq.com
• Study Contact Backup: Name: Lanyan Guo, MD, Ph.D; Phone Number: +86-18189145929; Email: guolany@163.com

Study Locations

• China
  • China/Shaan XI Province
    • Xi'an, China/Shaan XI Province, China
      • the First Affiliated Hospital of the Air Force Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Meet the clinical diagnostic criteria for HCM*;

2. 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:

1. Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;
2. Severe systemic hypertension and/or severe aortic stenosis (<1cm²);
3. Comorbid malignant tumors;
4. Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;
5. Comorbid with mental disorders;
6. Currently participating in other clinical trials and not reaching the primary endpoint.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertrophic cardiomyopathy; Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy.	Drug: Standard of care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	Incidence of individual components of MACE.	1, 6, 12, 24, 36, 60 months
Ischemic stroke	Incidence of individual components of MACE.	1, 6, 12, 24, 36, 60 months
Systemic embolism	Incidence of individual components of MACE.	1, 6, 12, 24, 36, 60 months
Malignant arrhythmia events	Incidence of individual components of MACE.	1, 6, 12, 24, 36, 60 months
Non-fatal myocardial infarction	Incidence of individual components of MACE.	1, 6, 12, 24, 36, 60 months
Rehospitalization for heart failure.	Incidence of individual components of MACE.	1, 6, 12, 24, 36, 60 months
All-cause mortality	Incidence of all-cause mortality.	1, 6, 12, 24, 36, 60 months
Number of rehospitalizations for heart failure	Total number of rehospitalizations for heart failure during follow-up.	1, 6, 12, 24, 36, 60 months
New-onset atrial arrhythmias	Incidence of new-onset atrial arrhythmias, including atrial tachycardia, atrial flutter, and atrial fibrillation.	1, 6, 12, 24, 36, 60 months
End-stage heart failure	Incidence of end-stage heart failure.	1, 6, 12, 24, 36, 60 months
Heart transplantation	Incidence of heart transplantation.	1, 6, 12, 24, 36, 60 months
Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy	Incidence of non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy.	1, 6, 12, 24, 36, 60 months
Anxiety/depressive mental disorders	Incidence of anxiety/depressive mental disorders.	1, 6, 12, 24, 36, 60 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) ≥5-point improvement	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.	1, 6, 12, 24, 36, 60 months
BARC 3 or 5 bleeding	Incidence of BARC 3 or 5 bleeding.	[1, 6, 12, 24, 36, 60 months]

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Ling Tao, MD, Ph.D, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathy, Hypertrophic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: KY20262041-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No