Clinical trial NCT06595992: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Official title: EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate Aortic Valve Stenosis
Moderate Aortic Valve Regurgitation
Aortic Valve Disease
Keywords: Aortic Valve Disease Progression
Mortality
Heart Failure
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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;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.

Brief summary: 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 \&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 (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\&#39;s condition and provide a scientific basis for clinical decision-making.

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

Primary outcomes:
measure: All cause mortality
timeFrame: 1-year, 3-year, and 5-year at follow-up
measure: Re-hospitalization related to heart failure.
timeFrame: 1-year, 3-year, and 5-year at follow-up
measure: Aortic valve replacement
timeFrame: 1-year, 3-year, and 5-year at follow-up
measure: Stroke
timeFrame: 1-year, 3-year, and 5-year at follow-up
Secondary outcomes:
measure: Change in echocardiography examination
timeFrame: 1-year, 3-year, and 5-year at follow-up
measure: Change in cardiac CT examination
timeFrame: 1-year, 3-year, and 5-year at follow-up
measure: Change in laboratory examination
timeFrame: 1-year, 3-year, and 5-year at follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University, School of Medicine
name: Jianan Wang, Dorctor
role: PRINCIPAL_INVESTIGATOR
References: