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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710788
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Mortality Drug: sevelamer phosphate-binders Drug: Calcium Carbonate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Multicenter, Prospective, Randomized Trial to Slow Down the Progression of Cardiovascular Calcifications to Reduce QTd in Incident Dialysis Patients
Study Start Date : January 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals

Arm Intervention/treatment
Experimental: 1
sevelamer as Phosphate-binder treatment
Drug: sevelamer phosphate-binders
1600 mg/day for 2 years
Other Name: Renagel

Active Comparator: 2
Calcium carbonate
Drug: Calcium Carbonate
Calcium carbonate 1 g/day for 2 years

Primary Outcome Measures :
  1. 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 Measures :
  1. QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710788

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Nephrology Division
Solofra, Avellino, Italy, 83100
Sponsors and Collaborators
Azienda Sanitaria ASL Avellino 2
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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
Publications of Results:

Other Publications:
Di Iorio B, D'Avanzo E, Piscopo C, Cucciniello E, Bellizzi V: QT and phosphatemia: a novel sensitive marker of cardiovascolar risk for an old killer . 12th Assisi European Meeting on Cardionephrology, Cardionephrology 10, Nuova BIOS ed, 2008;23-26

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Biagio Di Iorio, MD, PhD, Azienda Sanitaria ASL Avellino 2 Identifier: NCT00710788    
Other Study ID Numbers: 2008.1
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013
Keywords provided by Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2:
QT interval
QT dispersion
TC score
Additional relevant MeSH terms:
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Calcium Metabolism Disorders
Metabolic Diseases
Calcium Carbonate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Chelating Agents
Sequestering Agents