Status:
COMPLETED
Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis
Lead Sponsor:
Azienda Sanitaria ASL Avellino 2
Conditions:
Cardiovascular Mortality
Eligibility:
All Genders
18-75 years
Phase:
NA
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, e...
Eligibility Criteria
Inclusion
- incident patients on haemodialysis (CKD stage 5);
- an informed consent will be provided at the study entry.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00710788
Start Date
January 1 2007
End Date
September 1 2011
Last Update
February 12 2013
Active Locations (1)
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1
Nephrology Division
Solofra, Avellino, Italy, 83100