Comparing an Automatic PWV Analyser to Pulse Pressure in Hemodialysis

NCT02327962 | Completed

• 1 other identifier: LG2014
• Study Type: observational
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic kidney disease (CKD) accelerates vascular stiffening related to age. Arterial stiffness may be evaluated measuring the carotid-femoral pulse wave velocity (PWV) or more simply, as recommend by KDOQI, monitoring pulse pressure (PP). Both correlate to survival and incidence of cardiovascular disease. PWV can also be estimated on the brachial artery using a Mobil-O-Graph; a non-operator dependent automatic device. The aim was to analyse whether, in a dialysis population, PWV obtained by Mobil-O-Graph (MogPWV) is more sensitive for vascular aging than PP. A cohort of 143 patients from 4 dialysis units has been followed measuring MogPWV and PP every 3 to 6 months and compared to a control group of non-CKD patients.

Conditions

Vascular Stiffness

Outcome Measures

Primary Outcomes (1)

• Will the difference between groups be more significant using MogPWV (m/s) instead of PP (mmHg) as a parameter?

  Will PWV estimated by Mobil-O-Graph on the brachial artery, be more sensitive for vascular aging and better discriminate the dialysis population from the control group than pulse pressure?

  2 years

Secondary Outcomes (3)

• Will the change from baseline in MogPWV (m/s/y) be faster compared to the rate calculated for the previous years?

  2 years

• Are there specific risk factors that correlate to MogPWV progression?

  2 years

• Does mortality correlate to MogPWV?

  2 years

Study Arms (2)

Hemodialysis

Hemodynamic measurements with PWV

Control

Hemodynamic measurements with PWV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hemodialysis patients were recruited from 4 dialysis units located in the Italian-speaking part of Switzerland (Ospedale la Carità, Locarno; Ospedale San Giovanni, Bellinzona; Ospedale Civico, Lugano; Ospedale Beata Vergine, Mendrisio), starting from January 2011. Subjects of the control group were recruited among patients hospitalized at Ospedale la Carità, Locarno, for minor surgery and waiting for transfer or discharge.

You may qualify if:

• age 18 and older
• ability to understand the information presented and to sign the informed consent
• chronic hemodialysis for at least 8 weeks.

You may not qualify if:

• mental illness
• inability to understand the information presented and to sign the informed consent
• acute disease requiring hospitalization at the time of patient enrolment
• evidence of stenosis of the subclavian artery of the arm without shunt or of the non-shunt arm chosen to be used for the Mobil-O-Graph measurements
• atrial fibrillation.

Sponsors & Collaborators

• Ospedale Regionale di Locarno: lead

Related Publications (1)

• Salvade I, Schatti-Stahlin S, Violetti E, Schonholzer C, Cereghetti C, Zwahlen H, Berwert L, Burnier M, Gabutti L. A prospective observational study comparing a non-operator dependent automatic PWV analyser to pulse pressure, in assessing arterial stiffness in hemodialysis. BMC Nephrol. 2015 Apr 23;16:62. doi: 10.1186/s12882-015-0058-9.

  PMID: 25904000 DERIVED

Study Officials

• Luca Gabutti, MD

  Ente Ospedaliero Cantonale, Bellinzona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 31, 2014

Record last verified: 2014-12