Prospective Observational Cohort Study of Moderate Aortic Valve Disease

EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease; Moderate Aortic Valve Stenosis; Moderate Aortic Valve Regurgitation

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Xianbao Liu, Dorctor; Phone Number: 086-571-87784705; Email: liuxb@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University, School of Medicine
      • Contact: Xianbao Liu, Dorctor; Email: liuxb@zju.edu.cn
      • Principal Investigator: Jian'an Wang, Dorctor
      • Sub-Investigator: Xianbao Liu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 &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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jianan Wang, Dorctor, Second Affiliated Hospital of Zhejiang University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Mortality; Aortic Valve Disease Progression
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Ventricular Outflow Obstruction; Cardiovascular Abnormalities; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Defects, Congenital; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 2024-0357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No