ACTRN12622000447752Recruiting未知
A randomised trial evaluating the effect of phylloquinone on the progression of mild to moderate aortic stenosis
niversity of Western Australia0 sites108 target enrollmentStarted: March 21, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 108
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1) Aged 18+ years
- •2) Mild to moderate calcific aortic stenosis (peak flow velocity greater than 2.5m/s and less than 4m/s)
- •3) Valve area greater than 1 cm2
- •4) At least mild aortic valve calcification (Rosenhek category=1) on echocardiography.
Exclusion Criteria
- •1) Planned procedure to unblock heart arteries
- •2) Clinically important disease of any heart valve
- •3) Kidney disease (eGFR<40ml/min)
- •4) Intolerance to Vitamin-K
- •5) Prescribed a Vitamin-K blocker or supplement
- •6) Heart rhythm disturbance preventing a good quality CT-calcium score scan
- •7) Pregnancy
- •8) Unlikely to complete the 12 months follow-up.
Investigators
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