Status:
TERMINATED
Feasibility Study of Arterial Stiffness in Hemodialysis Patients
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Ottawa Hospital
University of Ottawa
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18+ years
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 a...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- Atrial fibrillation (as it frequently results in transient or persistent rapid heart rates and these changes overestimate aortic stiffness).
- Active cancer or history of cancer in the past 5 years.
- Pregnancy
- Any condition that limit the patient's ambulatory ability and preclude participation on this basis
- Mechanical, bioprosthetic heart valves or mechanical assisting devices (these conditions may change myocardial stiffness and the volumetric properties of the left ventricle leading to diastolic dysfunction and these physiologic changes may modify the waveforms of the cf- APWV).
- Pre-dialysis systolic blood pressure ≥ 200 mm Hg recorded in the last 6 dialysis treatments (2 weeks).
- Inability to measure blood pressure in at least one arm.
- Current smoker (\>15 cigarettes per day) in the last 6 months \[Daily cigarette consumption (\>15 cigarettes per day) adjusted by age, education level and other confounders has been found to be independently associated with the risk of hypertension\].
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02196610
Start Date
November 1 2014
End Date
March 1 2016
Last Update
May 2 2016
Active Locations (1)
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1
The Ottawa Hospital - Riverside campus
Ottawa, Ontario, Canada, K1H 7W9