Clinical Trials Logo
  1. Home
  2. Aortic Valve Stenosis
  3. NCT06466278
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03186339 - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Terminated NCT02854319 - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System N/A
Recruiting NCT05601453 - The ReTAVI Prospective Observational Registry
Withdrawn NCT05481814 - CPX in Paradoxical Low Flow Aortic Stenosis
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Completed NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease