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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00710788
Acronym
Independent
Enrollment
360
Registered
2008-07-04
Start date
2007-01-31
Completion date
2011-09-30
Last updated
2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Mortality

Keywords

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

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.

Interventions

DRUGsevelamer phosphate-binders

1600 mg/day for 2 years

DRUGCalcium Carbonate

Calcium carbonate 1 g/day for 2 years

Sponsors

Azienda Sanitaria ASL Avellino 2
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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 exclusions2 years

Secondary

MeasureTime frame
QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026