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| Name | Class |
|---|---|
| Army Medical Center of PLA | OTHER_GOV |
| Huaxi Hospital | OTHER |
| Fuwai Yunnan Cardiovascular Hospital | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 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 | 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. | 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. | 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up |
| Ventricular remodeling and deterioration of cardiac function |
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Inclusion Criteria:
At least 18 years old;
Be willing and able to provide informed consent to participate in the study;
Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital, Affiliated to Fuzhou University | Recruiting | Fuzhou | Fujian | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39966045 | Result | Lansac E, Veen KM, Joseph A, Blancarte Jaber P, Sossi F, Das-Gupta Z, Aktaa S, Sadaba JR, Thourani VH, Dahle G, Szeto WY, Bakaeen F, Aikawa E, Schoen FJ, Girdauskas E, Almeida A, Zuckermann A, Meuris B, Stott J, Kluin J, Meel R, Woan W, Colgan D, Jneid H, Balkhy H, Szerlip M, Preventza O, Shah P, Rigolin VH, Medica S, Holmes P, Sitges M, Pibarot P, Donal E, Hahn RT, Takkenberg JJM. The First International Consortium for Health Outcomes Measurement (ICHOM) Standard Dataset for Reporting Outcomes in Heart Valve Disease: Moving From Device- to Patient-Centered Outcomes: Developed by a multisociety taskforce coordinated by the Heart Valve Society (HVS) including the American Heart Association (AHA), the American College of Cardiology (ACC), the European Association for Cardio-Thoracic Surgery (EACTS), the European Society of Cardiology (ESC), The Society of Thoracic Surgeons (STS), the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS), the International Society for Applied Cardiovascular Biology (ISACB), the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), the South African Heart Association (SHA), Heart Valve Voice, and Global Heart Hub. JACC Adv. 2025 Apr;4(4):101059. doi: 10.1016/j.jacadv.2024.101059. Epub 2025 Feb 17. |
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| OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| The General Hospital of Northern Theater Command | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Fujian Provincial Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| The First Affiliated Hospital of Air Force Medicial University | OTHER |
| Navy General Hospital, Beijing | OTHER |
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The patient's blood sample is kept in a suitable way, centrifuged and aliquoted, etc., and stored in a -80° freezer。
Changes in indicators such as LVEF, LVEDD, or anteroposterior diameter of the atria as defined by echocardiography |
| 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 | 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. | 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up |
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | China |
|
| Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
|
| The General Hospital of Northern Theater Command | Recruiting | Shenyang | Liaoning | 110031 | China |
|
| The First Affiliated Hospital of Air Force Medicial University | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Huaxi Hospital | Recruiting | Chengdu | Sichuan | China |
|
| People's Hospital of Xinjiang Uygur Autonomous Region | Recruiting | Ürümqi | Xinjiang | 830000 | China |
|
| Fuwai Yunnan Cardiovascular Hospital | Recruiting | Kunming | Yunnan | 650032 | China |
|
| Second Affiliated Hospital of Zhejiang University, School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Recruiting | Beijing | China |
|
| Navy General Hospital, Beijing | Recruiting | Beijing | China |
|
| Army Medical Center of PLA | Recruiting | Chongqing | 400010 | China |
|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200080 | China |
|
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D005764 | Gastroesophageal Reflux |
| D008946 | Mitral Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| D014262 | Tricuspid Valve Insufficiency |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014694 | Ventricular Outflow Obstruction |
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