IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion (SALVAGE)

Phase 2

Active, not recruiting

• Conditions: Aortic valve stenosis

• Registration Number: 2024-517342-33-01
• Lead Sponsor: Amsterdam UMC Stichting

Brief Summary

To study the effect of icosapent ethyl on progression of aortic valve calcification.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-20
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Age > 50 years

Mild to moderate aortic valve stenosis

Exclusion Criteria

Bicuspid aortic valve

History of chest radiotherapy

History of rheumatic fever

Moderate to severe renal failure, defined as eGFR < 30 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in aortic valve calcium (AVC) score	2 years	continuous variable

Secondary Outcome Measures

Name	Time	Method
Change in peak aortic jet velocity at 24 months		Change in peak aortic jet velocity at 24 months
Change in calculated aortic valve area (AVA) at 24 months		Change in calculated aortic valve area (AVA) at 24 months
Total coronary plaque volume progression (mm2)		Total coronary plaque volume progression (mm2)
Non-calcified coronary plaque volume progression (mm2)		Non-calcified coronary plaque volume progression (mm2)

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands