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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Marcello Tonelli, University of Alberta
ClinicalTrials.gov Identifier:
NCT01427374
First received: August 30, 2011
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
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.

Condition
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Coronary Artery Calcification [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coronary Artery Calcification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Left ventricular mass [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Left ventricular mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Left ventricular hypertrophy [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
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.

Estimated Enrollment: 7000
Study Start Date: May 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Incident hemodialysis and peritoneal dialysis patients
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427374

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Washington
University of Washington
Seattle, Washington, United States, 98195U
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Massachusetts General Hospital
Investigators
Principal Investigator: Ravi Thadhani, MD, MPH Massachusetts General Hospital
Principal Investigator: Marcello Tonelli, MD, SM, FRCP University of Alberta
  More Information

Responsible Party: Marcello Tonelli, MD, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01427374     History of Changes
Other Study ID Numbers: 2011P000387  IRO 90262 
Study First Received: August 30, 2011
Last Updated: May 4, 2016
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Alberta:
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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Hypertrophy
Calcinosis
Hypertrophy, Left Ventricular
Arteriosclerosis
Coronary Artery Disease
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Calcium Metabolism Disorders
Metabolic Diseases
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Myocardial Ischemia

ClinicalTrials.gov processed this record on August 24, 2016