IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06466278

Acronym

SALVAGE

Enrollment

110

Registered

2024-06-20

Start date

2023-06-01

Completion date

2026-12-01

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Brief summary

This study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.

Interventions

DRUGIcosapent ethyl

2dd2

DRUGPlacebo

2dd2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age \> 50 years 2. Mild to moderate AVS

Exclusion criteria

1. Bicuspid aortic valve 2. History of chest radiotherapy 3. History of rheumatic fever 4. Moderate to severe renal failure, defined as eGFR \< 30 ml/min 5. Hyperparathyroidism 6. Paget's disease 7. Diagnosis of (active) malignancy in last 5 years 8. Anticipated or planned aortic valve surgery in the next 6 months 9. Life expectancy \<2 years 10. Chronic atrial fibrillation 11. Use of anticoagulant medication or dual antiplatelet therapy 12. Known hypersensitivity to fish and/or shellfish 13. Known hypersensitivity to soya 14. Malabsorption syndrome and/or chronic diarrhea 15. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control \[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\] to avoid pregnancy for the entire study. 16. Women who are pregnant or breastfeeding 17. Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator 18. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study

Design outcomes

Primary

Measure	Time frame	Description
Change in aortic valve calcium (AVC) score	2 years	continuous variable

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026