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

• ClinicalTrials.gov Identifier: NCT01427374
• Recruitment Status: Terminated
• First Posted: September 1, 2011
• Last Update Posted: May 1, 2018
• Sponsor: University of Alberta
• Collaborator: Massachusetts General Hospital
• Information provided by (Responsible Party): Marcello Tonelli, University of Alberta

Tracking Information

• First Submitted Date: August 30, 2011
• First Posted Date: September 1, 2011
• Last Update Posted Date: May 1, 2018
• Actual Study Start Date: May 2011
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 16, 2012): Coronary Artery Calcification [ Time Frame: baseline ]

Original Primary Outcome Measures (submitted: August 30, 2011)

Patient characteristics, comorbid diseases, lab markers (used in routine practice), novel biochemical markers and genetic data will be collected and analyzed to improve understanding of cardiovascular risk factors in patients with kidney disease. [ Time Frame: Longitudinal Study (~3-5 years) ]

Prospective cohort study of incident hemodialysis and peritoneal dialysis patients

Current Secondary Outcome Measures (submitted: May 16, 2012)

• 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 ]

Original Secondary Outcome Measures (submitted: August 30, 2011)

To determine (using biochemical and genetic markers) whether the risk of CAC and LVH associated with certain medications used by ESRD patients is modified by a genetic predisposition. [ Time Frame: Longitudinal study (~3-5 years) ]

To utilize data from the subset of patients in the LUCID cohort (who consent to participate in the cardiac imaging substudy) to test the following hypotheses about the independent relationship between biochemical and genetic markers and cardiovascular risk:

1. Specific clinical and biochemical parameters are strongly associated with the presence of coronary artery calcification (CAC).
2. Genetic epidemiological studies will identify novel loci that will be robustly associated with the presence of CAC and left ventricular hypertrophy (LVH) at baseline, and with LVH progression.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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).

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood and urine will be obtained at baseline, 6 months and annually thereafter. Blood samples will be immediately divided into multiple aliquots, from which plasma, DNA, RNA and/or cells will be extracted and separately stored. Urine specimens will also be aliquoted to allow future measurement of genetic and cellular material. Specimens will be labeled using unique study identifiers to maintain confidentiality.

• Sampling Method: Non-Probability Sample
• Study Population: Incident hemodialysis and peritoneal dialysis patients
• Condition: End Stage Renal Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 24, 2017): 30
• Original Estimated Enrollment (submitted: August 30, 2011): 7000
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT01427374
• Other Study ID Numbers: 2011P000387; IRO 90262 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Marcello Tonelli, University of Alberta
• Original Responsible Party: Marcello Tonelli, University of Alberta
• Current Study Sponsor: University of Alberta
• Original Study Sponsor: Same as current
• Collaborators: Massachusetts General Hospital

Investigators

• Principal Investigator: Ravi Thadhani, MD, MPH; Massachusetts General Hospital
• Principal Investigator: Marcello Tonelli, MD, SM, FRCP; University of Alberta

• PRS Account: University of Alberta
• Verification Date: April 2018