A Real-world HCM-cohort Trial
ConditionHypertrophic Cardiomyopathy (HCM)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
An expected enrollment of 3,000 HCM patients will be enrolled within the next 2 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard of care
DrugStandard of care
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Hypertrophic cardiomyopathy1 intervention
Trial outcomes
Primary outcomes
1
MACE
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.
Time frame
1, 6, 12, 24, 36, 60 monthsSecondary outcomes
1
Cardiac death
Incidence of individual components of MACE.
Time frame
1, 6, 12, 24, 36, 60 months2
Ischemic stroke
Incidence of individual components of MACE.
Time frame
1, 6, 12, 24, 36, 60 months3
Systemic embolism
Incidence of individual components of MACE.
Time frame
1, 6, 12, 24, 36, 60 months4
Malignant arrhythmia events
Incidence of individual components of MACE.
Time frame
1, 6, 12, 24, 36, 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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