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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Running Zhang, BSc
- 전화번호: +86-15802990370
- 이메일: running-zhang@qq.com
연구 연락처 백업
- 이름: Lanyan Guo, MD, Ph.D
- 전화번호: +86-18189145929
- 이메일: guolany@163.com
연구 장소
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China/Shaan XI Province
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Xi'an, China/Shaan XI Province, 중국
- The First Affiliated Hospital of the Air Force Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Meet the clinical diagnostic criteria for HCM*;
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:
- Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;
- Severe systemic hypertension and/or severe aortic stenosis (<1cm²);
- Comorbid malignant tumors;
- Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;
- Comorbid with mental disorders;
- Currently participating in other clinical trials and not reaching the primary endpoint.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Hypertrophic cardiomyopathy
Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy.
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치료의 표준
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MACE
기간: 1, 6, 12, 24, 36, 60 months
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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.
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1, 6, 12, 24, 36, 60 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiac death
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
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Ischemic stroke
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
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Systemic embolism
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
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Malignant arrhythmia events
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
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Non-fatal myocardial infarction
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
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Rehospitalization for heart failure.
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
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All-cause mortality
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of all-cause mortality.
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1, 6, 12, 24, 36, 60 months
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Number of rehospitalizations for heart failure
기간: 1, 6, 12, 24, 36, 60 months
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Total number of rehospitalizations for heart failure during follow-up.
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1, 6, 12, 24, 36, 60 months
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New-onset atrial arrhythmias
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of new-onset atrial arrhythmias, including atrial tachycardia, atrial flutter, and atrial fibrillation.
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1, 6, 12, 24, 36, 60 months
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End-stage heart failure
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of end-stage heart failure.
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1, 6, 12, 24, 36, 60 months
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Heart transplantation
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of heart transplantation.
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1, 6, 12, 24, 36, 60 months
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Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy.
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1, 6, 12, 24, 36, 60 months
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Anxiety/depressive mental disorders
기간: 1, 6, 12, 24, 36, 60 months
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Incidence of anxiety/depressive mental disorders.
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1, 6, 12, 24, 36, 60 months
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The Kansas City Cardiomyopathy Questionnaire (KCCQ) ≥5-point improvement
기간: 1, 6, 12, 24, 36, 60 months
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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.
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1, 6, 12, 24, 36, 60 months
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BARC 3 or 5 bleeding
기간: [1, 6, 12, 24, 36, 60 months]
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Incidence of BARC 3 or 5 bleeding.
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[1, 6, 12, 24, 36, 60 months]
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Ling Tao, MD, Ph.D, Xijing Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KY20262041-C-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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