Aortic Valve StenosisNCT06648915
Lipoprotein(a) and Progression of Aortic Stenosis
An observational study of Aortic Valve Stenosis and Lipoprotein(a), run by Asan Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Lipoprotein(a)
- What is being tested?
- Lipoprotein(a)
- How many people
- 364 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2025to Feb 2026
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent measurement of Lp(a) and had a diagnosis of mild to moderate, degenerative AVS between 2000 and 2020
Who may be able to join
- 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
Who cannot join
- Bicuspid AVS
- Rheumatic AVS
- Marked bradycardia, tachycardia or 2nd or 3rd degree AV block
- LV ejection fraction < 40%
- Hypertrophic or restrictive cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Valve Stenosis, Lipoprotein(a)
- Being tested
- Lipoprotein(a)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with mild to moderate AVS | Patients with measurements of Lp(a) and mild to moderate AVS Receives: Diagnostic Test: Lipoprotein(a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized change in peak aortic jet velocity
Measured: 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
Measured: 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)
Measured: From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
Occurrence of all-cause mortality
Measured: From enrollment to the registry to performance of the last follow-up echocardiographic examination, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start10 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duk-Hyun Kang, Asan Medical Center
- Investigators
- Duk-Hyun Kang, MD. PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648915
- Sponsor's protocol ID
- 2024-1209
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Lipoprotein(a) With Progression of Degenerative Aortic Valve Stenosis: Propensity-matched Study
- ClinicalTrials.gov ID
- NCT06648915
- Acronym / sponsor ID
- 2024-1209
- Conditions
- Aortic Valve Stenosis, Lipoprotein(a)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mild to moderate AVS | – | Diagnostic Test: Lipoprotein(a)Patients with measurements of Lp(a) and mild to moderate AVS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent measurement of Lp(a) and had a diagnosis of mild to moderate, degenerative AVS between 2000 and 2020
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Bicuspid AVS
- Rheumatic AVS
- Marked bradycardia, tachycardia or 2nd or 3rd degree AV block
- LV ejection fraction < 40%
- Hypertrophic or restrictive cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipoprotein(a)Measurement of Lp(a) was performed at the time of entry to the registry. Lp(a) level was measured using immunenephelometric assay | Diagnostic test | Patients with mild to moderate AVS |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk-Hyun Kang, MD. PhD. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Lipoprotein(a), run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.