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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier:
NCT00710788
First received: July 2, 2008
Last updated: February 9, 2013
Last verified: February 2013
History of Changes

July 2, 2008
February 9, 2013
January 2007
September 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00710788 on ClinicalTrials.gov Archive Site
QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
QT interval [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiovascular Mortality
  • Drug: sevelamer phosphate-binders
    1600 mg/day for 2 years
    Other Name: Renagel
  • Drug: Calcium Carbonate
    Calcium carbonate 1 g/day for 2 years
  • Experimental: 1
    sevelamer as Phosphate-binder treatment
    Intervention: Drug: sevelamer phosphate-binders
  • Active Comparator: 2
    Calcium carbonate
    Intervention: Drug: Calcium Carbonate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
September 2011
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00710788
2008.1, 2008.1.brd.renagel
Yes
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2
Azienda Sanitaria ASL Avellino 2
Not Provided
Study Chair: Biagio R Di Iorio, MD, PhD ASL AV/2, Avellino, Italy
Principal Investigator: Loreto Gesualdo, professor Nephrology Division, Medical School, University of Foggia
Principal Investigator: Filippo Aucella, MD ASL FG, Italy
Principal Investigator: Walter De Simone, MD AO MOscati, Avellino, Italy
Principal Investigator: Mario Migliorati, MD Dialysis, Torre del Greco, Italy
Principal Investigator: Domenico Santoro, MD Nephrology Division, Medical School, University of Messina, Italy
Principal Investigator: Pasquale Guastaferro, MD Nephrology Division, ASL AV1, Sant'Angelo de Lomnardi, Italy
Principal Investigator: Luigi Chiuchuilo, MD Dialysis, Avellino, Italy
Principal Investigator: Vincenzo Tedesco, MD Dialysis, Montella, Italy
Azienda Sanitaria ASL Avellino 2
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP