The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.
This study is a prospective observational cohort study designed to investigate the disease progression, medication and surgical intervention patterns, outcomes, and influencing factors in patients with moderate or greater cardiac valve stenosis and Grade II or higher cardiac valve regurgitation. The study population includes patients diagnosed at 15 major medical institutions in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine and West China Hospital of Sichuan University. The severity of valvular heart disease is determined according to a standardized dataset (JACC Adv. 2025 Apr) developed by a joint task force comprising multiple international societies. Currently, there is a lack of clear consensus regarding the management of patients with moderate valvular stenosis and regurgitation, and their subsequent disease progression remains poorly understood. Notably, the time span for progression from moderate to severe valvular heart disease can vary from 1 to 10 years, and monitoring and early warning mechanisms for potential early markers indicating disease deterioration are currently underdeveloped. Furthermore, patients with severe valvular heart disease may experience different outcomes following various device implantations, and the associated risk factors require further clarification. The objective of this study is to identify all clinical, biological, echocardiographic, and imaging parameters that may increase the risk of disease progression or adverse outcomes through a prospective observational cohort design. The confirmation of these parameters will guide future research in developing pharmacological and interventional treatment strategies to reduce mortality associated with this disease. Patients enrolled in this study will undergo annual outpatient follow-up visits after diagnosis, which will include electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans. Through these comprehensive monitoring methods, we aim to accurately assess changes in patients' conditions and provide a scientific basis for clinical decision-making.
Study Type
OBSERVATIONAL
Enrollment
10,000
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian, China
RECRUITINGRenmin Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGSecond Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe General Hospital of Northern Theater Command
Shenyang, Liaoning, China
RECRUITINGThe First Affiliated Hospital of Air Force Medicial University
Xi'an, Shaanxi, China
RECRUITINGAffiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGHuaxi Hospital
Chengdu, Sichuan, China
RECRUITINGPeople's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
RECRUITINGFuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China
RECRUITING...and 5 more locations
All cause mortality
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Heart valve replacement or repair
Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Stroke
Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Re-hospitalization related to cardiovascular disease
Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Progression of valve stenosis or regurgitation
Progression from moderate valvular stenosis to severe stenosis, or from grade II valvular regurgitation to more severe regurgitation, as defined by the echocardiographic examination.
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Ventricular remodeling and deterioration of cardiac function
Changes in indicators such as LVEF, LVEDD, or anteroposterior diameter of the atria as defined by echocardiography
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Changes in quality of life and symptoms
NYHA functional class, six-minute walk distance, or newly developed or worsening typical symptoms
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Newly Emerging Cardiovascular Disease and Complications
Such as newly onset arrhythmic events (including atrial fibrillation/flutter, conduction block, sick sinus syndrome, etc.), non-hospitalized heart failure-related events, bleeding events, thrombotic events, hypertensive emergencies, and symptoms related to myocardial ischemia.
Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.