Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01427374
• Other study ID #: 2011P000387
• Secondary ID: IRO 90262
• Status: Terminated
• Start date: May 2011
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Disease
• End Stage Renal Disease
• Hypertrophy
• Hypertrophy, Left Ventricular
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Calcification		baseline
Secondary	Coronary Artery Calcification		12 months
Secondary	Left ventricular mass		baseline
Secondary	Left ventricular mass		12 months
Secondary	All cause mortality		12 months
Secondary	Left ventricular hypertrophy		baseline