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Feasibility Study of Arterial Stiffness in Hemodialysis Patients

Arterial Stiffness in Healthy Subjects and Patients With End-Stage- Renal Disease: A Feasibility Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02196610
Enrollment
36
Registered
2014-07-22
Start date
2014-11-30
Completion date
2016-03-31
Last updated
2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Keywords

End-Stage Renal Disease,, arterial or vascular stiffness,, hemodialysis,, Pulse wave velocity, Renal insufficiency,, tonometry

Brief summary

People with kidney failure have a higher chance of getting disease in the blood vessels and this result in a decreased elasticity of the arteries of their body which make them very stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a method called applanation tonometry, which measures the pulse wave velocity of major blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is to determine if we can measure arterial stiffness reliably and accurately using this method in healthy people and in people with kidney failure receiving hemodialysis treatments at our centre. Also, we would like to know how stiff these arteries in healthy people are. If we demonstrate that the method is reliable and accurate in these 2 groups of participants at our centre, a future larger study is planned to determine if we can use measures of arterial stiffness to evaluate the risk of stroke and heart disease in people with kidney failure receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside Campus.

Detailed description

Background: Cardiovascular (CV) disease is a major cause of morbidity and mortality in patients with end-stage renal disease (ESRD). Arterial stiffness measured by pulse-wave velocity (PWV) has been identified as an independent predictor of fatal CV events in these patients. Our long-term goal is to study the impact of interventions that decrease progressive arterial stiffness on CV mortality in ESRD patients. Thus, we postulate that measurements of PWV during these interventions will predict CV outcome. Before studying this relationship, establishing the feasibility of PWV measurements at our centre is necessary. Objectives: i) To demonstrate the reliability and accuracy of arterial PWV measurements in healthy subjects and patients with ESRD at our centre, ii) To assess subject satisfaction and level of discomfort associated with the testing procedure, iii) To characterize normative values for the PWV in our two subject groups, and iv) To determine the feasibility of recruitment of patients with ESRD, as a pre-requisite for a larger trial focused on CV outcomes. Methods: PWV will be measured consecutively by 2 research assistants in: a) a group of 20 healthy subjects; and b) a group of 20 patients with ESRD on chronic hemodialysis at The Ottawa Hospital. Two consecutive sets of PWV measurements with a time-interval of 1 week (± 2 days) will be obtained in the healthy and ESRD groups (pre-hemodialysis, between 2 consecutive mid-week hemodialysis sessions). To determine the impact of hemodialysis on PWV measures, in a sub-group of 10 ESRD subjects measurements will be taken before and after hemodialysis. The order of testing by the 2 assistants will be randomized.

Interventions

Two consecutive sets of carotid-femoral Pulse Wave Velocity (PWV) measurements by Applanation tonometry with a time-interval of 1 week will be obtained (1 week ± 2 days). Two research assistants will each perform a carotid-femoral-PWV measurement at each time point with the testing order randomized.

Sponsors

The Ottawa Hospital
CollaboratorOTHER
University of Ottawa
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

HEALTHY SUBJECT GROUP Inclusion criteria: * Age: \>18 years * Able to provide informed consent

Exclusion criteria

* History of cardiovascular disease and/or hypertension (blood pressure \>140/90 mm Hg) * History of diabetes mellitus * History of liver or kidney disease, cancer and/or any lymphoproliferative disease * Currently receiving medication for any medical condition or illness * Body Mass Index (BMI) ≥ 30 Kg/m2 * Pregnancy * Any condition that limits functional ability and precludes participation * Current smoker (\>15 cigarettes per day) in the last 6 months. * Former smoker (\> 20 cigarettes per day) who stopped smoking \< 2 years ago. * Excessive alcohol intake (men \>14 drinks per week; women: \> 9 drinks per week). * Psychoactive or performance-enhancing drug abuse. END-STAGE RENAL DISEASE (ESRD) GROUP Inclusion Criteria: * Adult patient (age: \>18 years) with ESRD (estimated glomerular filtration rate: \<15 ml/min/m2) * Receiving hemodialysis treatments, with no expected renal recovery * Having received regular in-Centre Hemodialysis at TOH for at least the past 3 weeks * Able to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Reliability of carotid-femoral Pulse Wave Velocity measurements1 weekWe will estimate the Pulse Wave Velocity differences and the intra-class correlation coefficient (ICC) between the 2 examinations (test-retest) recorded in the same subject 1 week apart. We will also estimate the examiner's reliability by the inter-rater agreement through the ICC and limits of agreement.

Secondary

MeasureTime frameDescription
Accuracy of the carotid-femoral Pulse Wave Velocity measurements1 weekThis will be estimated by calculating the mean, standard deviation and 95% confidence interval of the Pulse Wave Velocity differences between our healthy group and the age-adjusted mean values from a historical healthy control group
Subject satisfaction and procedure discomfort1 weekThis will be accomplished by surveying subjects at the end of the testing procedure using a Likert-type questionnaire
Recruitment Efficacy11 monthsWe will assess the proportion of patients with End-Stage Renal disease (ESRD) who consented to the testing procedure relative to the number of eligible and screened participants

Other

MeasureTime frameDescription
Normative Pulse Wave Velocity Values11 monthsWe will calculate the mean, standard deviation and 95% confidence interval of the pulse wave velocity values and Augmentation index in our defined populations.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026