Lipoprotein(a) and Progression of Aortic Stenosis

December 25, 2025 updated by: Duk-Hyun Kang, Asan Medical Center

Association of Lipoprotein(a) With Progression of Degenerative Aortic Valve Stenosis: Propensity-matched Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Observational and genetic studies suggest that high levels of lipoprotein(a) (Lp[a]) increase the risk of calcific aortic valve stenosis (AVS). With the advancements of novel, specific therapies targeting Lp(a), there has been a growing need for clinical trials evaluating the effect of Lp(a) lowering in AVS. Requirement of longer follow-up time, selection of target populations and estimation of effect size are challenging issues for conducting clinical trials in AVS, and previous trials of statin therapy, which included patients with mild to moderate AVS, showed no significant effect of lowering LDL-cholesterol on the progression of AVS. Although post hoc analyses of previous statin trials showed that elevated levels of Lp(a) was associated with faster AVS progression, Lp(a) was associated with initiation but not with progression of AV calcification in a population-based study including 922 individuals. Because of a critical logistical challenge to randomized trials focusing the pre-calcific stages of AV disease, a clinical trial testing the progression of preexisting AVS is more feasible. The Lp(a)FRONTIERS CAVS trial (Assessing the Impact of Lipoprotein(a) Lowering with Pelacarsen (TQJ230) on the Progression of Calcific AVS; NCT05646381) will determine if pelacarsen can slow down the progression of AVS in patients with mild to moderate calcific AVS compared to placebo. To ensure adequate power to test the hypothesis of the ongoing Lp(a)FRONTIERS CAVS trial, it is important to estimate differences in progression of AS according to Lp(a) levels. However, such information is lacking and a well-designed prospective observational study is needed to directly compare progression of AS between the target population (patients with Lp(a) >70 mg/dL) of the Lp(a)FRONTIERS CAVS trial and control population (patients with mild to moderate AS and Lp(a) <30 mg/dL).

Investigators' prospective registry, started in 2001 at Asan Medical Center, has included all consecutive patients with measurements of Lp(a) and echocardiographic diagnosis of AVS. A total of 1381 patients underwent measurement of Lp(a) and had a diagnosis of mild to moderate, degenerative AVS between 2001 and 2020. Of the 1381 patients, 831 had Lp(a) level >70 mg/dL and 186 had Lp(a) level < 30 mg/dL. To reduce the effect of bias and potential confounding in this observational study, investigators performed rigorous adjustment for the differences in baseline characteristics using propensity-score matching. The propensity-score matched pairs were created by matching patients with Lp(a) >70 mg/dL and those with Lp(a) < 30 mg/dL in a 1:1 ratio. The primary cohort comprised 182 propensity-score matched pairs. The primary objective is to test the hypothesis that, compared with patients with Lp(a) < 30 mg/dL, those with Lp(a) >70 mg/dL have a faster progression of AVS in a propensity-matched cohort of patients with mild to moderate AVS. Investigators also try to evaluate interactions between Lp(a) groups and baseline clinical and echocardiographic variables for progression of AVS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with mild to moderate AVS
Patients with measurements of Lp(a) and mild to moderate AVS
Diagnostic test: Lipoprotein(a)
Measurement of Lp(a) was performed at the time of entry to the registry. Lp(a) level was measured using immunenephelometric assay

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Annualized change in peak aortic jet velocity
Time Frame: From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Annualized change in mean transvalvular gradient
Time Frame: From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
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)
Time Frame: From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
Occurrence of all-cause mortality
Time Frame: From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Duk-Hyun Kang, MD. PhD., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-1209

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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