Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate
Status:
Withdrawn
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel
calcifications, compared with the non-renal population. Both arterial stiffness and arterial
calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD
patients. Several studies have documented the direct relationship between the extent and
severity of arterial/coronary calcifications and outcome in dialysis patients. The
relationship is strong no matter if arterial calcifications were quantified by electron-beam
computed tomography or a radiological calcification score. Calcifications are early and
progressive events in these patients. PWV is strongly related to the degree of sonographic
determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic
kidney disease patients.
Calcium-based phosphate binders are associated with progressive coronary artery and aortic
calcification, especially when mineral metabolism is not well controlled.
According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing
phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders,
sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary
and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect
on the lipid profile.
Less is known about the relationship between sevelamer treatment and progression of arterial
stiffness. To date, there is one single study examining the influence of sevelamer (versus
calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of
haemodialysis patients. These study used the same patients as historical controls, thus being
methodologically rather weak. Moreover, the follow-up was quite short - 6 month.
The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the
effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse
wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate
these parameters with arterial calcification assessed by a previous described radiological
score of arterial calcification and echocardiographic parameters (left ventricular
hypertrophy, LV dilatation, systolic and diastolic dysfunction).