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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Running Zhang, BSc
- Telefonnummer: +86-15802990370
- E-post: running-zhang@qq.com
Studera Kontakt Backup
- Namn: Lanyan Guo, MD, Ph.D
- Telefonnummer: +86-18189145929
- E-post: guolany@163.com
Studieorter
-
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China/Shaan XI Province
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Xi'an, China/Shaan XI Province, Kina
- The First Affiliated Hospital of the Air Force Medical University
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Hypertrophic cardiomyopathy
Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy.
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Vårdstandard
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
MACE
Tidsram: 1, 6, 12, 24, 36, 60 months
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cardiac death
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Ischemic stroke
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Systemic embolism
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Malignant arrhythmia events
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Non-fatal myocardial infarction
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
Rehospitalization for heart failure.
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of individual components of MACE.
|
1, 6, 12, 24, 36, 60 months
|
|
All-cause mortality
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of all-cause mortality.
|
1, 6, 12, 24, 36, 60 months
|
|
Number of rehospitalizations for heart failure
Tidsram: 1, 6, 12, 24, 36, 60 months
|
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
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of new-onset atrial arrhythmias, including atrial tachycardia, atrial flutter, and atrial fibrillation.
|
1, 6, 12, 24, 36, 60 months
|
|
End-stage heart failure
Tidsram: 1, 6, 12, 24, 36, 60 months
|
Incidence of end-stage heart failure.
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1, 6, 12, 24, 36, 60 months
|
|
Heart transplantation
Tidsram: 1, 6, 12, 24, 36, 60 months
|
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
Tidsram: 1, 6, 12, 24, 36, 60 months
|
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
Tidsram: 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
Tidsram: 1, 6, 12, 24, 36, 60 months
|
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
Tidsram: [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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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Ling Tao, MD, Ph.D, Xijing Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KY20262041-C-1
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