aortic valve calcification aortic valve narrowing
Conditions
Interventions
Patients will be randomized to treatment with either icosapent ethyl or
matching placebo (in a 1:1 ratio).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age > 50 years 2. Mild to moderate AVS, defined as: (a) aortic valve maximum velocity by continuous wave doppler > 2,0 m/sec, and (b) aortic valve area >1,0 cm2 as calculated by continuity equation, and (c) morphologic evidence of aortic valve thickening, sclerosis or calcification.
Exclusion criteria
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. Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator 16. 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 |
|---|---|
| The primary outcome is the change in aortic valve calcium (AVC) at 24 months, calculated as follows: (final visit AVC - baseline visit AVC) / (days from baseline visit to final visit / 730). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are: • Change in peak aortic jet velocity at 24 months, calculated as follows: (final visit peak aortic jet velocity - baseline peak aortic jet velocity) / (days from baseline visit to final visit / 730). • Change in calculated aortic valve area (AVA) at 24 months, calculated as follows: (final visit calculated AVA - baseline calculated AVA) / (days from baseline visit to final visit / 730). • Total coronary plaque volume progression (mm2), calculated as follows: final total coronary plaque volume (mm2) - baseline total coronary plaque volume (mm2). • Non-calcified coronary plaque volume progression (mm2), calculated as follows: final non-calcified coronary plaque volume (mm2) - baseline non-calcified coronary plaque volume (mm2). | — |
Countries
Netherlands
Outcome results
None listed