Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Mortality

Intervention / Treatment
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* Drug: sevelamer phosphate-binders
* Drug: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sevelamer as Phosphate-binder treatment | Drug: sevelamer phosphate-binders<br>* 1600 mg/day for 2 years<br>* Other names: Renagel;|
| Active Comparator: 2<br>Calcium carbonate | Drug: Calcium Carbonate<br>* Calcium carbonate 1 g/day for 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QT interval, QT dispersion, arrhythmias, death, TC score