Hypertrophic Cardiomyopathy (HCM)HCMNCT06775665
A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- How many people
- 3,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2026to 1 Jun 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypertrophic cardiomyopathy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Xiaojie Xie, PhD, +86 571-87784700, xiexj@zju.edu.cn
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Xiaojie Xie, MD, PhD, 86+571-87784700, xiexj@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- No interventions were applied to the patients.
- Keywords
- hypertrophic cardiomyopathy, real-world study
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions were applied to the patients.Other
No interventions were applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No interventions were applied to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Cardiovascular Endpoints
Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death
Measured: 5 years
Secondary outcomes (11)
All-cause mortality
Rate of death resulting from any cause, encompassing both disease-related and non-disease-related factors
Measured: 5 years
Cardiovascular death
Rate of death resulting from cardiac diseases
Measured: 5 years
New-onset arrhythmia
Number of Participants with new-onset arrhythmia
Measured: 5 years
Sudden cardiac death (SCD)
Number of Participants suffer from sudden cardiac death
Measured: 5 years
Non-fatal acute myocardial infarction
Number of Participants suffer from non-fatal acute myocardial infarction
Measured: 5 years
Ischemic stroke
Number of participants suffer from ischemic stroke
Measured: 5 years
Heart failure hospitalization
The rehospitalization rate of participants due to heart failure
Measured: 5 years
New York Heart Association (NYHA) Classification
Percentage of participants with changes in NYHA classification
Measured: 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
Measured: 5 years
BNP/NT-proBNP
Changes in serum BNP/NT-proBNP concentrations compared to baseline
Measured: 5 years
Troponin T/I
Changes in serum cardiac troponin concentrations compared to baseline
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jun 2026
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojie Xie, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775665
- Sponsor's protocol ID
- 2024-1249
- Acronym
- HCM
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided