Clinical trial NCT01427374: Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients
Official title: Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: End Stage Renal Disease
Keywords: hemodialysis
peritoneal dialysis
chronic kidney disease
cardiovascular risk factors
cardiac imaging
dialysis
parathyroid hormone
vitamin D
coronary artery calcification
left ventricular hypertrophy
genetic predisposition
biochemical markers
infection
pharmacogenomics
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2011-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Incident hemodialysis and peritoneal dialysis patients

Brief 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Coronary Artery Calcification
timeFrame: baseline
Secondary outcomes:
measure: Coronary Artery Calcification
timeFrame: 12 months
measure: Left ventricular mass
timeFrame: baseline
measure: Left ventricular mass
timeFrame: 12 months
measure: All cause mortality
timeFrame: 12 months
measure: Left ventricular hypertrophy
timeFrame: baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Massachusetts General Hospital
name: Ravi Thadhani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Marcello Tonelli, MD, SM, FRCP
role: PRINCIPAL_INVESTIGATOR
References: