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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGAll cause mortality
Time frame: 1-year, 3-year, and 5-year at follow-up
Re-hospitalization related to heart failure.
Time frame: 1-year, 3-year, and 5-year at follow-up
Aortic valve replacement
Surgical Aortic Valve Replacement or Transcatheter Aortic Valve Replacement.
Time frame: 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.
Time frame: 1-year, 3-year, and 5-year at follow-up
Change in echocardiography examination
valvular mean gradient
Time frame: 1-year, 3-year, and 5-year at follow-up
Change in cardiac CT examination
Calcium volume or calcium volume
Time frame: 1-year, 3-year, and 5-year at follow-up
Change in laboratory examination
elevation of pro-BNP levels
Time frame: 1-year, 3-year, and 5-year at follow-up
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