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

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

Status and phase: Active, not recruiting; Phase 2

Conditions: Aortic Valve Stenosis

Treatments: Drug: Icosapent ethyl; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06466278

NL81780.018.22

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Medication

Experimental group

Treatment:

Drug: Icosapent ethyl

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo