Actively Recruiting
EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-09-19
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational cohort study to better understand the progression of moderate aortic valve disease, focusing on moderate aortic stenosis and regurgitation. The study aims to identify clinical, biological, echocardiographic, and CT imaging factors that may predict disease worsening and to analyze the potential impact of device or drug therapies on these conditions. This research addresses the current lack of clear treatment guidelines and monitoring methods for patients with moderate disease severity. Participants diagnosed with moderate aortic valve disease will be monitored regularly through outpatient follow-up visits every year after diagnosis. They will undergo electrocardiography, echocardiography, blood tests, and enhanced CT scans at 1, 3, and 5 years, with additional assessments if certain events occur. This comprehensive approach helps track disease changes and may guide future treatment decisions. During the study, researchers will measure outcomes such as all-cause mortality, re-hospitalization due to heart failure, aortic valve replacement, and stroke at 1, 3, and 5 years. They will also monitor changes in echocardiography, cardiac CT, and laboratory tests over the same time periods. The study includes safety monitoring and aims to provide a scientific basis for clinical care and decision-making in moderate aortic valve disease management.
CONDITIONS
Brief Title
Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Willing and able to provide informed consent
- Diagnosed with moderate aortic valve disease based on echocardiography criteria
You will not qualify if you...
- Severe aortic valve disease or planned/likely cardiac surgery within 6 months
- Previous elective transfemoral transcatheter aortic valve replacement
- Life expectancy under 12 months due to non-heart related illnesses
- Severe dementia preventing consent or self-care
- Acute pulmonary edema or cardiogenic shock
- Investigator judgement deeming patient unsuitable for study or follow-up
- Current participation in another randomized study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years or until an endpoint event occurs
Participants with moderate aortic valve disease are regularly monitored to assess disease progression through clinical characterization, biological tests, echocardiography, and CT imaging.
Outpatient follow-up visits every 1 year with electrocardiography, echocardiography, blood analysis, and enhanced CT examinations at 1, 3, and 5 years (plus once if an endpoint event occurs)
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xianbao Liu, Dorctor
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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