Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorYonsei University

About this trial

Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.

South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Period: 2010.1.1~2020.12.31

Age > 18 years

Moderate or severe native VHD (AS, AR, MR and TR)

Perform echocardiography more than twice

Disqualifiers

Poor image of echocardiography

Follow up loss

Trial population

This retrospective study includes adult patients (≥18 years) diagnosed with moderate or severe valvular heart disease (VHD) between January 1, 2010, and December 31, 2020, at tertiary hospitals in South Korea. Eligible patients must have undergone at least two transthoracic echocardiograms. Patients will be identified consecutively from echocardiographic and electronic medical record (EMR) databases. Exclusion criteria include congenital heart disease, prior valve surgery at baseline, and incomplete imaging or clinical data. Patients will be classified by valve type (aortic stenosis, aortic regurgitation, mitral regurgitation, tricuspid regurgitation), severity (moderate vs. severe), and etiology (degenerative, rheumatic, endocarditis, etc.). Demographic information such as age, sex, and comorbidities will be collected. The estimated sample size is expected to exceed 10,000 patients based on the number of participating centers and the 10-year study period.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

30,000 Participants
are grouped into 3 trial groups
Group A: Aortic petients
Group B: Mitral Patients
Group C: Tricuspid Patients

Trial outcomes

Primary outcomes

1

Prevalence of Moderate and Severe Valvular Heart Disease (VHD)

Evaluate the prevalence of moderate and severe VHD (including AS, AR, MR, and TR) based on echocardiographic findings and diagnostic records during the study period.

Time frame
January 1, 2010 - December 31, 2020
2

Etiological Classification of Aortic Stenosis (AS)

Classify AS cases retrospectively into degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy based on clinical records and imaging data.

Time frame
January 1, 2010 - December 31, 2020
3

Etiological Classification of Aortic Regurgitation (AR)

Categorize AR patients according to underlying causes: degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy.

Time frame
January 1, 2010 - December 31, 2020
4

Etiological Classification of Mitral Regurgitation (MR)

Retrospectively classify MR into primary MR (degenerative, mitral valve prolapse, rheumatic, endocarditis) and secondary MR (ventricular functional MR, atrial functional MR).

Time frame
January 1, 2010 - December 31, 2020

Secondary outcomes

1

All-Cause and Cardiovascular Mortality

Assess the incidence of all-cause mortality and cardiovascular-specific mortality among patients with valvular heart disease, using hospital records and national death registry data (if available).

Time frame
From initial diagnosis to date of death or last follow-up (within 2010-2020)
2

Treatment Pathway by Disease Severity

Evaluate how the treatment approach (medical management, surgical valve repair/replacement, or transcatheter intervention) varies according to disease severity (mild, moderate, severe) across different types of VHD.

Time frame
From initial diagnosis to date of death or last follow-up (within 2010-2020)

Other outcomes

Sponsors and contacts

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