IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssio

Phase 2

Recruiting

Conditions: aortic valve calcification
aortic valve narrowing
10046973

Registration Number: NL-OMON51414

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 110

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the change in aortic valve calcium (AVC) at 24 months,<br /><br>calculated as follows: (final visit AVC - baseline visit AVC) / (days from<br /><br>baseline visit to final visit / 730).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are:<br /><br>• Change in peak aortic jet velocity at 24 months, calculated as follows:<br /><br>(final visit peak aortic jet velocity - baseline peak aortic jet velocity) /<br /><br>(days from baseline visit to final visit / 730).<br /><br>• Change in calculated aortic valve area (AVA) at 24 months, calculated as<br /><br>follows: (final visit calculated AVA - baseline calculated AVA) / (days from<br /><br>baseline visit to final visit / 730).<br /><br>• Total coronary plaque volume progression (mm2), calculated as follows: final<br /><br>total coronary plaque volume (mm2) - baseline total coronary plaque volume<br /><br>(mm2).<br /><br>• Non-calcified coronary plaque volume progression (mm2), calculated as<br /><br>follows: final non-calcified coronary plaque volume (mm2) - baseline<br /><br>non-calcified coronary plaque volume (mm2). </p><br>