Trial | NCT00710788  Report issue

Title

Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis
Interventional, Multicenter, Prospective, Randomized Trial to Slow Down the Progression of Cardiovascular Calcifications to Reduce QTd in Incident Dialysis Patients

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    360
Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.
The risk of developing cardiovascular diseases in patients on hemodialysis is higher than in general population. Higher levels of serum phosphate are associated with adverse cardiovascular outcomes, especially in the setting of overt hyperphosphatemia. Given the biological importance of serum phosphorus, it is conceivable that also within the normal range values the higher serum phosphate levels may be associated with the worst outcome. Several paper have shown that vascular calcifications in dialysis patients are associated with increased relative risk of death; it has also been demonstrated in uremic patients that vascular calcifications decrease arterial elasticity. We previously observed that vascular calcification directly correlate with QT interval (QTc) as well as QT dispersion (QTd) in dialysis. Also, QT correction (obtained by the correction of phosphoremia and dyslipidemia) can ameliorate the development of arrhythmia and sudden death. Aim of this study is to evaluate the relationship between vascular calcifications and both QTd increase and mortality in incident hemodialysis patients, and to investigate the efficacy of sevelamer to reduce vascular calcifications and QTd.
Study Started
Jan 31
2007
Primary Completion
Sep 30
2010
Study Completion
Sep 30
2011
Last Update
Feb 12
2013
Estimate

Drug sevelamer phosphate-binders

1600 mg/day for 2 years

  • Other names: Renagel

Drug Calcium Carbonate

Calcium carbonate 1 g/day for 2 years

1 Experimental

sevelamer as Phosphate-binder treatment

2 Active Comparator

Calcium carbonate

Criteria 

Inclusion Criteria:

incident patients on haemodialysis (CKD stage 5);
an informed consent will be provided at the study entry.

Exclusion Criteria:

congenital prolongation of QT segment syndrome;
QTc >440 ms; increased QTd;
bradycardia <50 bpm;
sintomatic arrhythmia or any other significant heart problems;
electrolyte unbalances (especially hypokalemia, hypomagnesemia, hypocalcemia);
abnormal liver function tests;
hypothyroidism.
No Results Posted