Lipoprotein(a) and Progression of Aortic Stenosis

NCT06648915 | Active Not Recruiting

• 1 other identifier: 2024-1209
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, observational, two arm parallel group, clinical study involving patients with measurements of Lp(a) and mild to moderate aortic stenosis. A total of 1381 patients underwent measurement of Lp(a) and had a diagnosis of mild to moderate, degenerative aortic stenosis between 2001 and 2020 in Asan Medical Center. Investigators selected a propensity-matched cohort of patients with Lp(a) \>70 mg/dL and those with Lp(a) \<30 mg/dL from the registry of patients with mild to moderate aortic stenosis to control risk factors for progression of aortic stenosis, and try to prospectively compare progression of aortic stenosis between the two groups (Lp(a) \>70 mg/dL versus Lp(a) \< 30 mg/dL). Investigators also evaluate interactions between Lp(a) groups and baseline clinical and echocardiographic variables for progression of aortic stenosis.

Conditions

Aortic Valve Stenosis; Lipoprotein(a)

Outcome Measures

Primary Outcomes (1)

• Annualized change in peak aortic jet velocity

  From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months

Secondary Outcomes (3)

• Annualized change in mean transvalvular gradient

  From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months

• Occurrence of the composite of cardiovascular events (progression to severe aortic stenosis, aortic valve replacement, or cardiovascular mortality)

  From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months

• Occurrence of all-cause mortality

  From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months

Study Arms (1)

Patients with mild to moderate AVS

Patients with measurements of Lp(a) and mild to moderate AVS

Diagnostic Test: Lipoprotein(a)

Interventions

Lipoprotein(a) DIAGNOSTIC_TEST

Measurement of Lp(a) was performed at the time of entry to the registry. Lp(a) level was measured using immunenephelometric assay

Patients with mild to moderate AVS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent measurement of Lp(a) and had a diagnosis of mild to moderate, degenerative AVS between 2000 and 2020

You may qualify if:

• Mild to moderate degenerative AVS Aortic peak velocity greater than 2 m/s and smaller than 4 m/s
• LP(a) \>70 mg/dL or \<30 mg/dL
• Patients must provide written informed consent

You may not qualify if:

• Bicuspid AVS
• Rheumatic AVS
• Marked bradycardia, tachycardia or 2nd or 3rd degree AV block
• LV ejection fraction \< 40%
• Hypertrophic or restrictive cardiomyopathy

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Duk-Hyun Kang, MD. PhD.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: February 10, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)