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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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:
1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \>3 mm, jet width / LVOT diameter ≥25%, jet cross-sectional area/LVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.
2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m/s, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²/m², or velocity ratio ≤0.50.
3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area/left atrial area \>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².
4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.
5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.
6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \>60 cm, T1/2 ≥190 ms, or valve area ≤1.0 cm².
7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².
8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \<1.5 cm².
Exclusion Criteria:
* Patients who are unwilling to accept registration and follow-up;
* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;
* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).
Primary outcome measure(s)
All cause mortality — 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Heart valve replacement or repair — 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair
Stroke — 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
Re-hospitalization related to cardiovascular disease — 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.
Trial sites (15)
Facility
City
Region
Status
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou
Fujian
Recruiting
Renmin Hospital of Wuhan University
Wuhan
Hubei
Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
Second Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
The General Hospital of Northern Theater Command
Shenyang
Liaoning
Recruiting
The First Affiliated Hospital of Air Force Medicial University
Xi'an
Shaanxi
Recruiting
Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
Huaxi Hospital
Chengdu
Sichuan
Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi
Xinjiang
Recruiting
Fuwai Yunnan Cardiovascular Hospital
Kunming
Yunnan
Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou
Zhejiang
Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing
China
Recruiting
Navy General Hospital, Beijing
Beijing
China
Recruiting
Army Medical Center of PLA
Chongqing
China
Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
China
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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