Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Real-world HCM-cohort Trial

4. juni 2026 oppdatert av: Ling Tao, MD, PhD, Xijing Hospital

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

3000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Lanyan Guo, MD, Ph.D
  • Telefonnummer: +86-18189145929
  • E-post: guolany@163.com

Studiesteder

  • Kina
    • China/Shaan XI Province
      • Xi'an, China/Shaan XI Province, Kina
        • The First Affiliated Hospital of the Air Force Medical University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

An expected enrollment of 3,000 HCM patients will be enrolled within the next 2 years.

Beskrivelse

Inclusion Criteria:

  1. Meet the clinical diagnostic criteria for HCM*;

  2. 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:

  1. Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;
  2. Severe systemic hypertension and/or severe aortic stenosis (<1cm²);
  3. Comorbid malignant tumors;
  4. Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;
  5. Comorbid with mental disorders;
  6. Currently participating in other clinical trials and not reaching the primary endpoint.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Hypertrophic cardiomyopathy
Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy.
Legemiddel: Velferdstandard
Velferdstandard

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MACE
Tidsramme: 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.
1, 6, 12, 24, 36, 60 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cardiac death
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
1, 6, 12, 24, 36, 60 months
Ischemic stroke
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
1, 6, 12, 24, 36, 60 months
Systemic embolism
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
1, 6, 12, 24, 36, 60 months
Malignant arrhythmia events
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
1, 6, 12, 24, 36, 60 months
Non-fatal myocardial infarction
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
1, 6, 12, 24, 36, 60 months
Rehospitalization for heart failure.
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
1, 6, 12, 24, 36, 60 months
All-cause mortality
Tidsramme: 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
Tidsramme: 1, 6, 12, 24, 36, 60 months
Total number of rehospitalizations for heart failure during follow-up.
1, 6, 12, 24, 36, 60 months
New-onset atrial arrhythmias
Tidsramme: 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
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of end-stage heart failure.
1, 6, 12, 24, 36, 60 months
Heart transplantation
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of heart transplantation.
1, 6, 12, 24, 36, 60 months
Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy.
1, 6, 12, 24, 36, 60 months
Anxiety/depressive mental disorders
Tidsramme: 1, 6, 12, 24, 36, 60 months
Incidence of anxiety/depressive mental disorders.
1, 6, 12, 24, 36, 60 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) ≥5-point improvement
Tidsramme: 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.
1, 6, 12, 24, 36, 60 months
BARC 3 or 5 bleeding
Tidsramme: [1, 6, 12, 24, 36, 60 months]
Incidence of BARC 3 or 5 bleeding.
[1, 6, 12, 24, 36, 60 months]

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xijing Hospital

Etterforskere

  • Studiestol: Ling Tao, MD, Ph.D, Xijing Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juni 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

23. februar 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY20262041-C-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere