A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population (HCM)

Clinical Characteristics and Real-World Outcomes of Chinese Patients With Hypertrophic Cardiomyopathy: A Prospective Cohort Study

This study is a prospective cohort study aimed at exploring the baseline characteristics and treatment patterns of the Chinese population with hypertrophic cardiomyopathy (HCM) in real-world settings. The objective is to assess the real-world treatment approaches and longitudinal outcomes in this population.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertrophic Cardiomyopathy (HCM)
• Intervention / Treatment: Other: No interventions were applied to the patients.

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

Contacts and Locations

• Study Contact: Name: Jianqiang Song, MD; Phone Number: +86 15267083207; Email: 22318324@zju.edu.cn
• Study Contact Backup: Name: Shitian Guo, MD; Phone Number: +86 571-87784700; Email: 22218352@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Xiaojie Xie, PhD; Phone Number: +86 571-87784700; Email: xiexj@zju.edu.cn

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertrophic cardiomyopathy

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent (ICF) and any required privacy authorization before the start of the study.
2. Aged ≥18 years at the time of signing the written informed consent.

3. Diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, meeting the following criteria:

   1. Left ventricular wall thickness ≥15 mm in any segment at end-diastole, as assessed by echocardiography or cardiac magnetic resonance imaging (MRI).
   2. Left ventricular wall thickness ≥13 mm in individuals with a positive pathogenic gene test or those identified as members of a genetically affected family.
   3. Exclusion of other cardiovascular diseases or systemic/metabolic diseases causing ventricular wall thickening.

Exclusion Criteria:

1. Uncontrolled primary hypertension.
2. Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation.
3. Confirmed infiltrative or storage diseases with a phenotype resembling hypertrophic cardiomyopathy (e.g., Fabry disease, amyloidosis).
4. Expected life expectancy <1 years.
5. Severe infections, liver failure, renal failure, or other life-threatening conditions.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

HCM; Patients diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy were consecutively enrolled. These patients received pharmacological, interventional, or surgical treatment based on real-world treatment strategies. Follow-up was conducted to observe patient prognosis and the occurrence of outcome events.

Other: No interventions were applied to the patients.; No interventions were applied to the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Cardiovascular Endpoints	Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New York Heart Association (NYHA) Classification	Percentage of participants with changes in NYHA classification	5 years
Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)	The KCCQ-23 is a disease-specific health status assessment tool consisting of 23 items that quantify physical limitation, symptoms, self-efficacy, social limitation, and quality of life related to heart failure. Scores range from 0 to 100, with higher scores indicating better health status	5 years
BNP/NT-proBNP	Changes in serum BNP/NT-proBNP concentrations compared to baseline	5 years
Troponin T/I	Changes in serum cardiac troponin concentrations compared to baseline	5 years
All-cause mortality	Rate of death resulting from any cause, encompassing both disease-related and non-disease-related factors	5 years
Cardiovascular death	Rate of death resulting from cardiac diseases	5 years
New-onset arrhythmia	Number of Participants with new-onset arrhythmia	5 years
Sudden cardiac death (SCD)	Number of Participants suffer from sudden cardiac death	5 years
Non-fatal acute myocardial infarction	Number of Participants suffer from non-fatal acute myocardial infarction	5 years
Ischemic stroke	Number of participants suffer from ischemic stroke	5 years
Heart failure hospitalization	The rehospitalization rate of participants due to heart failure	5 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Xiaojie Xie, PhD, Second Affiliated Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: hypertrophic cardiomyopathy; real-world study
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
• Other Study ID Numbers: 2024-1249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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