Prospective Observational Cohort Study of Moderate Aortic Valve Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Moderate Aortic Valve Stenosis, Moderate Aortic Valve Regurgitation, Aortic Valve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Overview
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.
Detailed description
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.
Primary outcome measures
- All 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 [Time frame: 1-year, 3-year, and 5-year at follow-up]
- Stroke [Time frame: 1-year, 3-year, and 5-year at follow-up]
Secondary outcome measures (3)
- Change in echocardiography examination [Time frame: 1-year, 3-year, and 5-year at follow-up]
- Change in cardiac CT examination [Time frame: 1-year, 3-year, and 5-year at follow-up]
- Change in laboratory examination [Time frame: 1-year, 3-year, and 5-year at follow-up]
Eligibility criteria
Inclusion criteria
- At least 18 years old
- Be willing and able to provide informed consent to participate in the study
- Patient has moderate aortic valve diseases with echocardiographically derived criteria
Exclusion criteria
- Severe aortic valve diseases with echocardiographically derived criteria or planned cardiac surgery or likely need for surgery within 6 months
- Patients who have undergone elective transfemoral transcatheter aortic valve replacement
- Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.)
- Severe dementia (cannot sign research informed consent, cannot take care of themselves or complete the study visit)
- Acute pulmonary oedema or cardiogenic shock
- The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects
- The patient is currently participating in another randomized study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou
Identifiers
NCT: NCT06595992 · 2024-0357