Feasibility Study of Arterial Stiffness in Hemodialysis Patients

NCT02196610 | Terminated

• 1 other identifier: 20140457
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reliability of carotid-femoral Pulse Wave Velocity measurements

  We 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.

  1 week

Secondary Outcomes (3)

• Accuracy of the carotid-femoral Pulse Wave Velocity measurements

  1 week

• Subject satisfaction and procedure discomfort

  1 week

• Recruitment Efficacy

  11 months

Other Outcomes (1)

• Normative Pulse Wave Velocity Values

  11 months

Study Arms (2)

HEALTHY SUBJECTS group

A group of 20 healthy staff volunteers identified from the Division of Nephrology, Dept. of Medicine and the Kidney Research Centre at the Ottawa Hospital Research Institute will be invited to participate. Measurements of arterial stiffness will be performed by Applanation tonometry. Healthy status will be defined by a self-reporting questionnaire obtained over the phone prior to enrolment and 2 subsequent non-invasive measurements of arterial blood pressure (BP) prior to testing. Subjects will be included if diastolic BP is ≤ 90 mm Hg and systolic BP ≤ 140 mm Hg on 2 consecutive measurements.

Other: Applanation tonometry

END-STAGE RENAL DISEASE (ESRD) group

A group of 20 patients with stage 5 Chronic Kidney Disease (estimated glomerular filtration rate \<15 ml/min/m2), who attend chronic hemodialysis treatments at The Ottawa Hospital (TOH) will be invited to participate. Measurements of arterial stiffness will be performed in this group by Applanation tonometry.

Other: Applanation tonometry

Interventions

Applanation tonometry OTHER

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.

Also known as: carotid-femoral Pulse wave velocity (c-f-PWV)

END-STAGE RENAL DISEASE (ESRD) group; HEALTHY SUBJECTS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HEALTHY SUBJECTS: 20 healthy staff volunteers. ESRD group: 20 patients with stage 5 CKD (estimated GFR \<15 ml/min/m2), who attend chronic hemodialysis treatments at The Ottawa Hospital (TOH).

You may qualify if:

• Age: \>18 years
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital: collaborator
• University of Ottawa: collaborator

Study Sites (1)

The Ottawa Hospital - Riverside campus

Ottawa, Ontario, K1H 7W9, Canada

Location

Related Publications (13)

• Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.

  PMID: 15385656 BACKGROUND

• Moody WE, Edwards NC, Chue CD, Ferro CJ, Townend JN. Arterial disease in chronic kidney disease. Heart. 2013 Mar;99(6):365-72. doi: 10.1136/heartjnl-2012-302818. Epub 2012 Oct 31.

  PMID: 23118349 BACKGROUND

• Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.

  PMID: 20338492 BACKGROUND

• Guerin AP, Blacher J, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness attenuation on survival of patients in end-stage renal failure. Circulation. 2001 Feb 20;103(7):987-92. doi: 10.1161/01.cir.103.7.987.

  PMID: 11181474 BACKGROUND

• Karras A, Haymann JP, Bozec E, Metzger M, Jacquot C, Maruani G, Houillier P, Froissart M, Stengel B, Guardiola P, Laurent S, Boutouyrie P, Briet M; Nephro Test Study Group. Large artery stiffening and remodeling are independently associated with all-cause mortality and cardiovascular events in chronic kidney disease. Hypertension. 2012 Dec;60(6):1451-7. doi: 10.1161/HYPERTENSIONAHA.112.197210. Epub 2012 Oct 22.

  PMID: 23090769 BACKGROUND

• Pannier B, Guerin AP, Marchais SJ, Safar ME, London GM. Stiffness of capacitive and conduit arteries: prognostic significance for end-stage renal disease patients. Hypertension. 2005 Apr;45(4):592-6. doi: 10.1161/01.HYP.0000159190.71253.c3. Epub 2005 Mar 7.

  PMID: 15753232 BACKGROUND

• Boutouyrie P, Fliser D, Goldsmith D, Covic A, Wiecek A, Ortiz A, Martinez-Castelao A, Lindholm B, Massy ZA, Suleymanlar G, Sicari R, Gargani L, Parati G, Mallamaci F, Zoccali C, London GM. Assessment of arterial stiffness for clinical and epidemiological studies: methodological considerations for validation and entry into the European Renal and Cardiovascular Medicine registry. Nephrol Dial Transplant. 2014 Feb;29(2):232-9. doi: 10.1093/ndt/gft309. Epub 2013 Sep 30.

  PMID: 24084326 BACKGROUND

• Frimodt-Moller M, Nielsen AH, Kamper AL, Strandgaard S. Reproducibility of pulse-wave analysis and pulse-wave velocity determination in chronic kidney disease. Nephrol Dial Transplant. 2008 Feb;23(2):594-600. doi: 10.1093/ndt/gfm470. Epub 2007 Nov 7.

  PMID: 17989106 BACKGROUND

• Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.

  PMID: 20530030 BACKGROUND

• Pan CR, Schmaderer C, Roos M, von Eynatten M, Sollinger D, Lutz J, Heemann U, Baumann M. Comparing aortic stiffness in kidney transplant recipients, hemodialysis patients, and patients with chronic renal failure. Clin Transplant. 2011 Jul-Aug;25(4):E463-8. doi: 10.1111/j.1399-0012.2011.01462.x. Epub 2011 Apr 26.

  PMID: 21517999 BACKGROUND

• Giraudeau B, Mary JY. Planning a reproducibility study: how many subjects and how many replicates per subject for an expected width of the 95 per cent confidence interval of the intraclass correlation coefficient. Stat Med. 2001 Nov 15;20(21):3205-14. doi: 10.1002/sim.935.

  PMID: 11746313 BACKGROUND

• Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.

  PMID: 21453829 BACKGROUND

• Rodriguez RA, Cronin V, Ramsay T, Zimmerman D, Ruzicka M, Burns KD. Reproducibility of carotid-femoral pulse wave velocity in end-stage renal disease patients: methodological considerations. Can J Kidney Health Dis. 2016 Apr 1;3:20. doi: 10.1186/s40697-016-0109-6. eCollection 2016.

  PMID: 27042326 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Burns, MD, CM

  Ottawa Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)