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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01427374
Recruitment Status : Terminated (low recruitment)
First Posted : September 1, 2011
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Marcello Tonelli, University of Alberta

Study Description
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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.

Condition or disease
End Stage Renal Disease

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
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)
Actual Study Start Date : May 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Coronary Artery Calcification [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Coronary Artery Calcification [ Time Frame: 12 months ]
  2. Left ventricular mass [ Time Frame: baseline ]
  3. Left ventricular mass [ Time Frame: 12 months ]
  4. All cause mortality [ Time Frame: 12 months ]
  5. Left ventricular hypertrophy [ Time Frame: baseline ]

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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427374


Locations
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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
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Principal Investigator: Ravi Thadhani, MD, MPH Massachusetts General Hospital
Principal Investigator: Marcello Tonelli, MD, SM, FRCP University of Alberta
More Information
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Responsible Party: Marcello Tonelli, MD, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01427374    
Other Study ID Numbers: 2011P000387
IRO 90262 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by Marcello Tonelli, 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:
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Kidney Failure, Chronic
Hypertrophy, Left Ventricular
Calcinosis
Hypertrophy
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Pathological Conditions, Anatomical
Calcium Metabolism Disorders
Metabolic Diseases
Cardiomegaly
Heart Diseases
Cardiovascular Diseases