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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
  Purpose

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


Condition Intervention
Cardiovascular Mortality
 Drug: sevelamer phosphate-binders
Drug: Calcium Carbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Sanitaria ASL Avellino 2:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 360
Study Start Date: January 2007
Study Completion Date: September 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710788

Locations
Italy
Nephrology Division
Solofra, Avellino, Italy, 83100
Sponsors and Collaborators
Azienda Sanitaria ASL Avellino 2
Investigators
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
  More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Biagio Di Iorio, MD, PhD, Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier: NCT00710788     History of Changes
Other Study ID Numbers: 2008.1, 2008.1.brd.renagel
Study First Received: July 2, 2008
Last Updated: February 9, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Sanitaria ASL Avellino 2:
QT interval
QT dispersion
arrhythmias
death
TC score

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Calcium Carbonate
Sevelamer
 Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Chelating Agents

ClinicalTrials.gov processed this record on May 16, 2013