Hypertrophic Cardiomyopathy (HCM)
Conditions
Keywords
hypertrophic cardiomyopathy, real-world study
Brief summary
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.
Interventions
OTHERNo interventions were applied to the patients.
No interventions were applied to the patients.
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Cardiovascular Endpoints | 5 years | Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 5 years | Rate of death resulting from any cause, encompassing both disease-related and non-disease-related factors |
| Cardiovascular death | 5 years | Rate of death resulting from cardiac diseases |
| New-onset arrhythmia | 5 years | Number of Participants with new-onset arrhythmia |
| Sudden cardiac death (SCD) | 5 years | Number of Participants suffer from sudden cardiac death |
| Non-fatal acute myocardial infarction | 5 years | Number of Participants suffer from non-fatal acute myocardial infarction |
| Ischemic stroke | 5 years | Number of participants suffer from ischemic stroke |
| Heart failure hospitalization | 5 years | The rehospitalization rate of participants due to heart failure |
| New York Heart Association (NYHA) Classification | 5 years | Percentage of participants with changes in NYHA classification |
| Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) | 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 | 5 years | Changes in serum BNP/NT-proBNP concentrations compared to baseline |
| Troponin T/I | 5 years | Changes in serum cardiac troponin concentrations compared to baseline |
Countries
China
Contacts
CONTACTJianqiang Song, MD
CONTACTShitian Guo, MD
PRINCIPAL_INVESTIGATORXiaojie Xie, PhD
Second Affiliated Hospital, Zhejiang University, School of Medicine
Outcome results
None listed