Observing Progression and Outcomes in Adults with Moderate or Severe Heart Valve Disease Using Imaging and Clinical Data
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-05
10000
Participants Needed
15
Research Sites
126 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the progression of moderate or greater cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, CT, and MRI data. The study aims to better understand disease progression, outcomes, and the effects of device interventions, medications, and lifestyle changes. It addresses the current lack of consensus on managing moderate valvular heart disease and the need for improved early warning mechanisms.
This observational cohort study involves patients diagnosed with heart valve disease at major medical centers in China. Participants will be followed annually with outpatient visits including electrocardiography, echocardiography, blood tests, and contrast-enhanced CT scans. The study collects standardized data to identify factors that influence disease progression and adverse outcomes, guiding future treatment research.
Participants will be monitored over several years with yearly assessments to track mortality, heart valve surgery, stroke, rehospitalization, valve disease progression, cardiac function, quality of life, and new cardiovascular complications. The study uses comprehensive imaging and clinical data to provide a scientific basis for improving clinical decision-making and patient care in valvular heart disease.
CONDITIONS
Brief Title
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
Army Medical Center of PLA
Collaborating Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
At least 18 years old
Willing and able to provide informed consent
Diagnosed with heart valve disease meeting one or more of these criteria:
Grade II or higher aortic valve regurgitation with specific echocardiographic measurements
Moderate or higher aortic valve stenosis based on velocity, gradient, or valve area
Grade II or higher mitral valve regurgitation with defined jet width or volume
Moderate or higher valve stenosis with valve area or mean gradient thresholds
Grade II or higher tricuspid valve regurgitation with defined jet width or volume
Significant tricuspid valve stenosis with pressure gradient or valve area criteria
Grade II or higher pulmonary valve regurgitation with jet width or volume measures
Moderate or higher pulmonary valve stenosis with pressure gradient or valve area limits
You will not qualify if you...
Unwilling to accept registration and follow-up
Unable to cooperate with data collection and follow-up due to mental illness or other conditions
Life expectancy less than 12 months due to non-cardiac diseases such as cancer, liver disease, kidney disease, or end-stage lung disease
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants undergo annual outpatient follow-up visits including electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans to monitor disease progression and outcomes.
Annual outpatient visits
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
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.
