Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis

Not Applicable

Completed

• Conditions: Cardiovascular Mortality
• Interventions: Drug: sevelamer phosphate-binders; Drug: Calcium Carbonate

• Registration Number: NCT00710788
• Lead Sponsor: Azienda Sanitaria ASL Avellino 2

Brief 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2010-09
• Study Completion: 2011-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-09
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sevelamer phosphate-binders	sevelamer as Phosphate-binder treatment
2	Calcium Carbonate	Calcium carbonate

Primary Outcome Measures

Name	Time	Method
death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions	2 years

Secondary Outcome Measures

Name	Time	Method
QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality	2 years

Trial Locations

Locations (1)

Nephrology Division; 🇮🇹 Solofra, Avellino, Italy