Prospective Observational Cohort Study of Moderate Aortic Valve Disease

NCT06595992 | Recruiting

• 1 other identifier: 2024-0357
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate Aortic Valve Stenosis; Moderate Aortic Valve Regurgitation; Aortic Valve Disease

Keywords

Aortic Valve Disease Progression; Mortality; Heart Failure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in echocardiography examination

  1-year, 3-year, and 5-year at follow-up

• Change in cardiac CT examination

  1-year, 3-year, and 5-year at follow-up

• Change in laboratory examination

  1-year, 3-year, and 5-year at follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \<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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The patient's blood sample is kept in a suitable way, centrifuged and aliquoted, etc., and stored in a -80° freezer。

MeSH Terms

Conditions

Aortic Valve Disease; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jianan Wang, Dorctor

  Second Affiliated Hospital of Zhejiang University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianbao Liu, Dorctor

CONTACT

086-571-87784705; liuxb@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)