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Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis (Independent)

Primary Purpose

Cardiovascular Mortality

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

sevelamer phosphate-binders

Calcium Carbonate

About this trial

This is an interventional treatment trial for Cardiovascular Mortality focused on measuring QT interval, QT dispersion, arrhythmias, death, TC score

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nephrology Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

sevelamer as Phosphate-binder treatment

Calcium carbonate

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality

Full Information

NCT ID

NCT00710788

First Posted

July 2, 2008

Last Updated

February 9, 2013

Sponsor

Azienda Sanitaria ASL Avellino 2

1. Study Identification

Unique Protocol Identification Number

NCT00710788

Brief Title

Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis

Acronym

Independent

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Sanitaria ASL Avellino 2

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Mortality

Keywords

QT interval, QT dispersion, arrhythmias, death, TC score

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

sevelamer as Phosphate-binder treatment

Arm Title

Arm Type

Active Comparator

Arm Description

Calcium carbonate

Intervention Type

Drug

Intervention Name(s)

sevelamer phosphate-binders

Other Intervention Name(s)

Renagel

Intervention Description

1600 mg/day for 2 years

Intervention Type

Drug

Intervention Name(s)

Calcium Carbonate

Intervention Description

Calcium carbonate 1 g/day for 2 years

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: