IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion (SALVAGE)

September 30, 2025 updated by: Matthijs Boekholdt, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
This study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Center

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
2dd2
Experimental: Medication
Drug: Icosapent ethyl
2dd2

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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)

June 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL81780.018.22

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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