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NCT06466278 Clinical Trial

IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

Aortic Valve Stenosis Clinical Trial

— SALVAGE  

Official title:
IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06466278
Other study ID # NL81780.018.22
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2023
Est. completion date December 1, 2026

Study information
Verified date May 2024
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Matthijs Boekholdt, MD, PhD
Phone 020 566 9111
Email s.m.boekholdt@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date December 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Icosapent ethyl
2dd2
• Placebo
2dd2

Locations
Country Name City State
Netherlands Academic Medical Center Amsterdam

Sponsors (1)
Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in aortic valve calcium (AVC) score 2 years
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