2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009, China
Not Yet Recruiting
NCT Number: NCT06775665
A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Willing and able to provide written informed consent (ICF) and any required privacy authorization before the start of the study.
- Aged ≥18 years at the time of signing the written informed consent.
- Diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, meeting the following criteria:
- Left ventricular wall thickness ≥15 mm in any segment at end-diastole, as assessed by echocardiography or cardiac magnetic resonance imaging (MRI).
- Left ventricular wall thickness ≥13 mm in individuals with a positive pathogenic gene test or those identified as members of a genetically affected family.
- Exclusion of other cardiovascular diseases or systemic/metabolic diseases causing ventricular wall thickening.
Exclusion criteria
- Uncontrolled primary hypertension.
- Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation.
- Confirmed infiltrative or storage diseases with a phenotype resembling hypertrophic cardiomyopathy (e.g., Fabry disease, amyloidosis).
- Expected life expectancy <1 years.
- Severe infections, liver failure, renal failure, or other life-threatening conditions.
Treatment and study plan
No interventions were applied to the patients.
OtherNo interventions were applied to the patients.
Primary outcomes
-
Composite Cardiovascular Endpoints
Time frame: 5 years
Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death
Secondary outcomes
-
All-cause mortality
Time frame: 5 years
Rate of death resulting from any cause, encompassing both disease-related and non-disease-related factors
-
Cardiovascular death
Time frame: 5 years
Rate of death resulting from cardiac diseases
-
New-onset arrhythmia
Time frame: 5 years
Number of Participants with new-onset arrhythmia
-
Sudden cardiac death (SCD)
Time frame: 5 years
Number of Participants suffer from sudden cardiac death
-
Non-fatal acute myocardial infarction
Time frame: 5 years
Number of Participants suffer from non-fatal acute myocardial infarction
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Ischemic stroke
Time frame: 5 years
Number of participants suffer from ischemic stroke
-
Heart failure hospitalization
Time frame: 5 years
The rehospitalization rate of participants due to heart failure
-
New York Heart Association (NYHA) Classification
Time frame: 5 years
Percentage of participants with changes in NYHA classification
-
Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Time frame: 5 years
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
-
BNP/NT-proBNP
Time frame: 5 years
Changes in serum BNP/NT-proBNP concentrations compared to baseline
-
Troponin T/I
Time frame: 5 years
Changes in serum cardiac troponin concentrations compared to baseline
Study contacts
Contact information is provided by the study sponsor or research team.
Jianqiang Song, MD
CONTACT
Shitian Guo, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Registry information
Official study title
Clinical Characteristics and Real-World Outcomes of Chinese Patients With Hypertrophic Cardiomyopathy: A Prospective Cohort Study
Acronym: HCM
Important dates
- Study start
- 2026
- Primary completion
- 2031
- Study completion
- 2032
- First posted
- Jan 15, 2025
- Registry last updated
- May 30, 2025
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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