NCT00710788

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Azienda Sanitaria ASL Avellino 2 · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.

Detailed description

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.

Conditions

• Cardiovascular Mortality

Interventions

Type	Name	Description
DRUG	sevelamer phosphate-binders	1600 mg/day for 2 years
DRUG	Calcium Carbonate	Calcium carbonate 1 g/day for 2 years

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-09-01
• Completion: 2011-09-01
• First posted: 2008-07-04
• Last updated: 2013-02-12

Locations

1 site across 1 country: Italy