Overview

This trial is active, not recruiting.

Condition end stage renal disease
Sponsor University of Alberta
Collaborator Massachusetts General Hospital
Start date May 2011
End date December 2017
Trial size 7000 participants
Trial identifier NCT01427374, 2011P000387, IRO 90262

Summary

Individuals with kidney disease are at a higher risk for heart and vascular diseases, including heart attacks and strokes, than those with normal kidney function. The purpose of this research study is to collect information on the causes, complications and treatment of kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data will be collected to examine relationships between biochemical and genetic markers and cardiovascular risk. Information on the health history of incident hemodialysis and peritoneal dialysis patients will be captured using structured patient interviews and review of medical records. Blood and urine specimens will be collected at the time of dialysis initiation and stored in order to perform novel biochemical and genetic assays in the future. The overall goal of the CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a subset of patients enrolled. The goals of the substudy are to examine whether the risks of developing common cardiac-related complications (coronary artery calcification [CAC] and left ventricular hypertrophy [LVH]) are associated with certain medications taken by individuals on dialysis and whether these risks are modified by a genotypic predisposition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Coronary Artery Calcification
time frame: baseline

Secondary Outcomes

Measure
Coronary Artery Calcification
time frame: 12 months
Left ventricular mass
time frame: baseline
Left ventricular mass
time frame: 12 months
All cause mortality
time frame: 12 months
Left ventricular hypertrophy
time frame: baseline

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis. Exclusion Criteria: • Unable to provide informed consent. Exclusion Criteria for the cardiac substudy: CT exclusion criteria 1. Pregnancy 2. Obesity (>275 lbs) 3. Rapid atrial fibrillation, bigeminy or trigeminy 4. Any condition that impedes the ability to lie flat during the CT (eg:decompensated congestive heart failure). MRI exclusion criteria 1. Cardiac pacemaker or implantable defibrillator 2. Obesity (>275lbs) 3. Intraocular metal 4. Cerebral aneurysm clips, programmable shunt, etc. 5. Any type of ear implant 6. Any implanted device (eg: insulin, drug infusion device) 7. Metal shrapnel or bullet 8. Any condition that impedes the ability to lie flat during the MRI (eg:decompensated congestive heart failure)

Additional Information

Official title Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)
Principal investigator Ravi Thadhani, MD, MPH
Description This study is being conducted under the Sponsorship of the University of Alberta (Edmonton, Alberta, Canada) and is funded by Canadian Institutes of Health Industry Partnered Research Grant IRO 90262 - with partnership funding from Abbott Laboratories. The co-Principal Investigators are Marcello Tonelli MD SM and Ravi Thadhani, MD, MPH . A total of 750 patients are anticipated being enrolled at Massachusetts General Hospital (MGH). The remaining patients are being enrolled in Canada. This study will utilize data from "The Canadian Kidney Disease Cohort Study" (CKDCS) and "The Longitudinal US/Canada Incident Dialysis STUDY (LUCID).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Alberta.