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

NCT07068633 | Not Yet Recruiting

• 1 other identifier: 4-2024-1451
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Mitral Valve Prolapse; Tricuspid Valve Insufficiency; Rheumatic Heart Disease; Aortic Diseases

Outcome Measures

Primary Outcomes (6)

• 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.

  January 1, 2010 - December 31, 2020

• 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.

  January 1, 2010 - December 31, 2020

• Etiological Classification of Aortic Regurgitation (AR)

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

  January 1, 2010 - December 31, 2020

• 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).

  January 1, 2010 - December 31, 2020

• Classification of Tricuspid Regurgitation (TR)

  Classify TR cases into primary and secondary based on echocardiographic findings and clinical context.

  January 1, 2010 - December 31, 2020

• Disease Progression and Treatment Pathway

  Analyze the time course of VHD progression from mild to moderate to severe and track the time to intervention (surgical or transcatheter) using retrospective patient records.

  January 1, 2010 - December 31, 2020

Secondary Outcomes (2)

• All-Cause and Cardiovascular Mortality

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

• Treatment Pathway by Disease Severity

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

Study Arms (3)

Aortic petients

Primary focus is aortic stenosis patients; secondary focus is aortic regurgitation.

Mitral Patients

Primary focus is Degenerative Mitral Regurgitation patients; secondary focus is Functional Mitral Regurgitation.

Tricuspid Patients

Primary focus is Tircuspid Regurgitation patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Poor image of echocardiography
• Follow up loss

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Mitral Valve Prolapse; Tricuspid Valve Insufficiency; Rheumatic Heart Disease; Aortic Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Valve Prolapse; Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vascular Diseases

Study Design

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

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

KR (1)