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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Running Zhang, BSc
- 電話番号：+86-15802990370
- メール：running-zhang@qq.com
研究連絡先のバックアップ
- 名前：Lanyan Guo, MD, Ph.D
- 電話番号：+86-18189145929
- メール：guolany@163.com
研究場所
-
-
China/Shaan XI Province
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Xi'an、China/Shaan XI Province、中国
- The First Affiliated Hospital of the Air Force Medical University
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Hypertrophic cardiomyopathy
Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy.
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標準治療
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MACE
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiac death
時間枠：1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
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1, 6, 12, 24, 36, 60 months
|
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Ischemic stroke
時間枠：1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Systemic embolism
時間枠：1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Malignant arrhythmia events
時間枠：1, 6, 12, 24, 36, 60 months
|
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
時間枠：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.
時間枠：1, 6, 12, 24, 36, 60 months
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Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
All-cause mortality
時間枠：1, 6, 12, 24, 36, 60 months
|
Incidence of all-cause mortality.
|
1, 6, 12, 24, 36, 60 months
|
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Number of rehospitalizations for heart failure
時間枠：1, 6, 12, 24, 36, 60 months
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Total number of rehospitalizations for heart failure during follow-up.
|
1, 6, 12, 24, 36, 60 months
|
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New-onset atrial arrhythmias
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：[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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協力者と研究者
スポンサー
捜査官
- スタディチェア：Ling Tao, MD, Ph.D、Xijing Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KY20262041-C-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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