IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion (SALVAGE)

Phase 2

Not yet recruiting

• Conditions: Aortic valve stenosis
• Interventions: Drug: Icosapent ethyl; Drug: Placebo

• Registration Number: 2024-517342-33-01
• Lead Sponsor: Amsterdam UMC Stichting

Brief Summary

To study the effect of icosapent ethyl on progression of aortic valve calcification.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Age > 50 years

Mild to moderate aortic valve stenosis

Exclusion Criteria

Bicuspid aortic valve

History of chest radiotherapy

History of rheumatic fever

Moderate to severe renal failure, defined as eGFR < 30 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication	Icosapent ethyl	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in aortic valve calcium (AVC) at 24 months		Change in aortic valve calcium (AVC) at 24 months

Secondary Outcome Measures

Name	Time	Method
Change in peak aortic jet velocity at 24 months		Change in peak aortic jet velocity at 24 months
Change in calculated aortic valve area (AVA) at 24 months		Change in calculated aortic valve area (AVA) at 24 months
Total coronary plaque volume progression (mm2)		Total coronary plaque volume progression (mm2)
Non-calcified coronary plaque volume progression (mm2)		Non-calcified coronary plaque volume progression (mm2)

Trial Locations

Locations (1)

Amsterdam UMC Stichting; 🇳🇱 Amsterdam, Netherlands

Amsterdam UMC Stichting

🇳🇱Amsterdam, Netherlands

Matthijs Boekholdt

Site contact

0205669111

s.m.boekholdt@amsterdamumc.nl