Using icosapent ethyl to slow down aortic valve stenosis progression
IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion
This study is testing if a fish oil-based medication can help slow down the worsening of aortic valve stenosis in people over 50 with mild to moderate cases.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06466278 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of icosapent ethyl, a medication derived from fish oil, on patients suffering from aortic valve stenosis. It aims to determine whether this treatment can slow the progression of the condition in individuals aged over 50 with mild to moderate aortic valve stenosis. Participants will be randomly assigned to receive either icosapent ethyl or a placebo, allowing for a comparison of outcomes between the two groups. The study is designed to gather data on the efficacy and safety of the treatment over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 50 years old diagnosed with mild to moderate aortic valve stenosis.
Not a fit: Patients with severe aortic valve stenosis, those requiring imminent surgical intervention, or individuals with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly slow the progression of aortic valve stenosis, potentially improving patient outcomes and quality of life.
How similar studies have performed: While there have been studies on the effects of omega-3 fatty acids on cardiovascular conditions, the specific use of icosapent ethyl for aortic valve stenosis is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam
- Academic Medical Center — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Matthijs Boekholdt, MD, PhD
- Email: s.m.boekholdt@amsterdamumc.nl
- Phone: 020 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.