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The objective of this research is to evaluate and predict the progression of moderate aortic stenosis and regurgitation from clinical characterization, biological, echocardiographic, and computed tomography (CT) et. al. Additionally, try to analyze the potential impact of device or drug therapy on the progression of the conditions.
This study is a prospective observational cohort study aimed at thoroughly investigating the disease progression and influencing factors of patients with moderate aortic valve disease, diagnosed at the Second Affiliated Hospital of Zhejiang University School of Medicine. Aortic valve stenosis and aortic regurgitation are the most common forms of aortic valve disease. According to the 2021 ESC guidelines, moderate aortic stenosis (Moderate AS) is defined as an aortic valve area (AVA) of 1.0-1.5 cm2 on echocardiography (or AVA <1.0 cm2 with an AVA index of 0.60-0.85 cm2/m2), a peak jet velocity (Vmax) of 3-4 m/s, and/or a mean transvalvular gradient (MG) of 20-40 mmHg. Moderate aortic regurgitation (Moderate AR) is defined as a regurgitant fraction between 30% and 50% or an effective regurgitant orifice area between 0.10-0.30 cm2.
While treatment guidelines for patients with severe AS are well-established, there is currently no clear consensus on the treatment of patients with moderate AS, and the subsequent disease progression for these patients remains unclear. Similarly, when the aortic valve shows only moderate regurgitation, surgical treatment is usually not required; the most important aspect is regular monitoring of disease changes, including regular echocardiographic examinations. It is noteworthy that the time span from moderate to severe aortic regurgitation can vary from 1 to 10 years, and the monitoring and early warning mechanisms for potential markers indicating disease deterioration are currently not well developed. The goal of this study is to identify all clinical characterization, biological, echocardiographic, and CT imaging parameters that may increase the risk of disease progression. The confirmation of these parameters will guide future research to develop medical and interventional treatment methods to reduce mortality associated with this disease. Patients participating in this study will undergo outpatient follow-up every 1 year after diagnosis and will undergo electrocardiography, echocardiography, blood analysis, and enhanced CT examinations at 1, 3, and 5 years (plus once if an endpoint event occurs). Through these comprehensive monitoring methods, we expect to more accurately assess changes in the patient's condition and provide a scientific basis for clinical decision-making.
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| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 1-year, 3-year, and 5-year at follow-up | |
| Re-hospitalization related to heart failure. | 1-year, 3-year, and 5-year at follow-up | |
| Aortic valve replacement | Surgical Aortic Valve Replacement or Transcatheter Aortic Valve Replacement. | 1-year, 3-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, 3-year, and 5-year at follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in echocardiography examination | valvular mean gradient | 1-year, 3-year, and 5-year at follow-up |
| Change in cardiac CT examination | Calcium volume or calcium volume |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a prospective observational cohort study aimed at thoroughly investigating the disease progression and influencing factors of patients with moderate aortic valve disease, diagnosed at the Second Affiliated Hospital of Zhejiang University School of Medicine. Aortic valve stenosis and aortic regurgitation are the most common forms of aortic valve disease. According to the 2021 ESC guidelines, moderate aortic stenosis (Moderate AS) is defined as an aortic valve area (AVA) of 1.0-1.5 cm2 on echocardiography (or AVA &amp;amp;lt;1.0 cm2 with an AVA index of 0.60-0.85 cm2/m2), a peak jet velocity (Vmax) of 3-4 m/s, and/or a mean transvalvular gradient of 20-40 mmHg. Moderate aortic regurgitation (Moderate AR) is defined as a regurgitant fraction between 30% and 50% or an effective regurgitant orifice area between 0.10-0.30 cm2.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianbao Liu, Dorctor | Contact | 086-571-87784705 | liuxb@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianan Wang, Dorctor | Second Affiliated Hospital of Zhejiang University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University, School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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。
| 1-year, 3-year, and 5-year at follow-up |
| Change in laboratory examination | elevation of pro-BNP levels | 1-year, 3-year, and 5-year at follow-up |