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

February 9, 2013 updated by: Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Avellino
      • Solofra, Avellino, Italy, 83100
        • Nephrology Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
sevelamer as Phosphate-binder treatment
Drug: sevelamer phosphate-binders
1600 mg/day for 2 years
Other Names:
  • Renagel
ACTIVE_COMPARATOR: 2
Calcium carbonate
Drug: Calcium Carbonate
Calcium carbonate 1 g/day for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 exclusions
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (ESTIMATE)

July 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 9, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.1
  • 2008.1.brd.renagel

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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