The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population. It will also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of vascular calcification in this group of patients. This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular events (MACE) over the same period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Oral supplement given post dialysis 3x/week
National University Hospital
Singapore, Singapore
Absolute difference in coronary artery calcium score at 18-month between control and intervention arms
Comparison made using the t-test following log transformation. Adjustment for baseline CAC scores made via the analysis of covariance.
Time frame: 18 months
Absolute difference in AVC score at 18-months
Comparison made using the t-test following log transformation. Adjustment for baseline AVC scores made via the analysis of covariance.
Time frame: 18 months
Percentage of patients with regression of CAC of ≥ 10% over 18-month
Time frame: 18 months
Absolute difference in cfPWV and AI at 18-months
Time frame: 18 months
Mortality from any cause within the study period
Time frame: 18 months
MACE defined as non-fatal myocardial infarction, heart failure, acute coronary syndrome, need for coronary revascularization, non-fatal stroke, significant peripheral vascular disease
Time frame: 18 months
Difference in plasma levels of dp-ucMGP at 18 months
Time frame: 18 months
Vascular access events, including clotting requiring insertion of a new dialysis catheter, declotting or exchange of an existing catheter, and vascular intervention during the study period
Time frame: 18 months
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