Evaluating the effects of Vitamin K supplements on Aortic Stenosis

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Calcific aortic stenosis is a condition in which build-up of calcium on the aortic valve, located at the outflow of the heart, progressively blocks blood flow to the organs and can cause debilitating symptoms and very poor survival. Timely replacement of the valve can be lifesaving but comes with significant risks and at high cost. The incidence is increasing in Australia. Until now there have been no treatments that can prevent the progressive obstruction of the aortic valve. Our pilot study showed that supplementation of Vitamin-K, 10mg per day is safe and can prevent all early types of calcification in the arteries. The double-blind, randomised, placebo-controlled PASSPORT trial will test whether Vitamin-K can slow or prevent the calcium build-up and obstruction of the aortic valve. 108 subjects with mild or moderate aortic stenosis on echocardiography will be randomised to Vitamin K1 10mg per day or matching placebo for a median duration of 16 months (range 12-21 months). All subjects will receive an echocardiogram and non-contrast CT-calcium score at baseline and at the end of the trial. The primary end point will be progression in aortic valve calcium score on CT scans and secondary outcomes will be progression of flow obstruction parameters as assessed by echocardiography.