the First Affiliated Hospital of the Air Force Medical University
Xi'an, China/Shaan XI Province, China
NCT Number: NCT07638033
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.
Trial opening soon.
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Observational
Xi'an, China/Shaan XI Province, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care
Time frame: 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.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of individual components of MACE.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of all-cause mortality.
Time frame: 1, 6, 12, 24, 36, 60 months
Total number of rehospitalizations for heart failure during follow-up.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of new-onset atrial arrhythmias, including atrial tachycardia, atrial flutter, and atrial fibrillation.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of end-stage heart failure.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of heart transplantation.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy.
Time frame: 1, 6, 12, 24, 36, 60 months
Incidence of anxiety/depressive mental disorders.
Time frame: 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.
Time frame: [1, 6, 12, 24, 36, 60 months]
Incidence of BARC 3 or 5 bleeding.
Contact information is provided by the study sponsor or research team.
Lanyan Guo, MD, Ph.D
CONTACT
Running Zhang, BSc
CONTACT
Xijing Hospital
Other
A Multicenter, Prospective, Real-world Study on Hypertrophic Cardiomyopathy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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