Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648915
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Lipoproteina and Progression of Aortic Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Association of Lipoproteina with Progression of Degenerative Aortic Valve Stenosis Propensity-matched Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective observational two arm parallel group clinical study involving patients with measurements of Lpa and mild to moderate aortic stenosis A total of 1381 patients underwent measurement of Lpa 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 Lpa 70 mgdL and those with Lpa 30 mgdL 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 Lpa 70 mgdL versus Lpa 30 mgdL Investigators also evaluate interactions between Lpa groups and baseline clinical and echocardiographic variables for progression of aortic stenosis
Detailed Description:
Observational and genetic studies suggest that high levels of lipoproteina Lpa increase the risk of calcific aortic valve stenosis AVS With the advancements of novel specific therapies targeting Lpa there has been a growing need for clinical trials evaluating the effect of Lpa 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 Lpa was associated with faster AVS progression Lpa 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 LpaFRONTIERS CAVS trial Assessing the Impact of Lipoproteina 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 LpaFRONTIERS CAVS trial it is important to estimate differences in progression of AS according to Lpa 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 Lpa 70 mgdL of the LpaFRONTIERS CAVS trial and control population patients with mild to moderate AS and Lpa 30 mgdL
Investigators prospective registry started in 2001 at Asan Medical Center has included all consecutive patients with measurements of Lpa and echocardiographic diagnosis of AVS A total of 1381 patients underwent measurement of Lpa and had a diagnosis of mild to moderate degenerative AVS between 2001 and 2020 Of the 1381 patients 831 had Lpa level 70 mgdL and 186 had Lpa level 30 mgdL 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 Lpa 70 mgdL and those with Lpa 30 mgdL in a 11 ratio The primary cohort comprised 182 propensity-score matched pairs The primary objective is to test the hypothesis that compared with patients with Lpa 30 mgdL those with Lpa 70 mgdL 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 Lpa groups and baseline clinical and echocardiographic variables for progression of AVS
Investigators prospective registry started in 2001 at Asan Medical Center has included all consecutive patients with measurements of Lpa and echocardiographic diagnosis of AVS A total of 1381 patients underwent measurement of Lpa and had a diagnosis of mild to moderate degenerative AVS between 2001 and 2020 Of the 1381 patients 831 had Lpa level 70 mgdL and 186 had Lpa level 30 mgdL 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 Lpa 70 mgdL and those with Lpa 30 mgdL in a 11 ratio The primary cohort comprised 182 propensity-score matched pairs The primary objective is to test the hypothesis that compared with patients with Lpa 30 mgdL those with Lpa 70 mgdL 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 Lpa groups and baseline clinical and echocardiographic variables for progression of AVS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None