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Longitudinal Change of Arterial Stiffness Indices in Relation to Ambulatory Aortic and Branchial Pressure in Long Term Peritoneal Dialysis Patients
This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. These parameters will be monitored both cross-sectionally at the start of the study and prospectively over a 6 month period.
All participants will be monitored over a 6 month period during which 7 monthly visits will be performed. Brachial and aortic blood pressure (BP), wave reflection and arterial stiffness indices will be assessed with the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). The above hemodynamic and arterial wall parameters will be measured for 24-hours on visits 1 (baseline) and 7 (month 6). The monitor will be set to obtain recordings 3 times/hour from 11:00 pm to 06:59 am and 2 times/hour from 07:00 am to 10:59 pm. Measurements will be used for the analysis if \>80% of recordings were valid with no more than two non-consecutive day hours with fewer than two valid measurements, and no more than one night hour without valid recording, according to recommendations for ambulatory BP monitoring. Bioelectrical Impendance Analysis (BIA) with the Fresenius Body Composition Monitor (BCM - Fresenius Medical Care, Bad Homberg, Germany) will be performed on visits 1, 4 and 6 in order to assess the hydration status and body composition parameters of the participants.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AHEPA University Hospital
Thessaloniki, Greece
Start Date
July 18, 2018
Primary Completion Date
August 30, 2020
Completion Date
August 30, 2020
Last Updated
January 7, 2020
40
ESTIMATED participants
Lead Sponsor
Aristotle University Of Thessaloniki
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04163614