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OpenTrials
Active, Not Recruiting

NCT Number: NCT06466278

IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 50 years
  • Mild to moderate AVS

Exclusion criteria

  • Bicuspid aortic valve
  • History of chest radiotherapy
  • History of rheumatic fever
  • Moderate to severe renal failure, defined as eGFR < 30 ml/min
  • Hyperparathyroidism
  • Paget's disease
  • Diagnosis of (active) malignancy in last 5 years
  • Anticipated or planned aortic valve surgery in the next 6 months
  • Life expectancy <2 years
  • Chronic atrial fibrillation
  • Use of anticoagulant medication or dual antiplatelet therapy
  • Known hypersensitivity to fish and/or shellfish
  • Known hypersensitivity to soya
  • Malabsorption syndrome and/or chronic diarrhea
  • 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.
  • Women who are pregnant or breastfeeding
  • Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
  • Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study

Treatment and study plan

Icosapent Ethyl

Drug

2dd2

Placebo

Drug

2dd2

Primary outcomes

  1. Change in aortic valve calcium (AVC) score

    Time frame: 2 years

    continuous variable

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: SALVAGE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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