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

Stopped early

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT01427374

Run by

University of Alberta

People needed

30

Starts

2011-05-01

Expected to finish

2017-12-01

Last updated by the study team

2018-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis.

You may not qualify if…

• Unable to provide informed consent.
• Exclusion Criteria for the cardiac substudy:
• CT exclusion criteria
• Pregnancy
• Obesity (>275 lbs)
• Rapid atrial fibrillation, bigeminy or trigeminy
• Any condition that impedes the ability to lie flat during the CT (eg:decompensated congestive heart failure).
• MRI exclusion criteria
• Cardiac pacemaker or implantable defibrillator
• Obesity (>275lbs)
• Intraocular metal
• Cerebral aneurysm clips, programmable shunt, etc.
• Any type of ear implant
• Any implanted device (eg: insulin, drug infusion device)
• Metal shrapnel or bullet
• Any condition that impedes the ability to lie flat during the MRI (eg:decompensated congestive heart failure)

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Washington — Seattle, Washington, United States
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.