Clinical trial NCT03607747: Relationship Between Blood Pressure and Pulse Wave Velocity Measurements in Peritoneal Dialysis
Official title: Longitudinal Change of Arterial Stiffness Indices in Relation to Ambulatory Aortic and Branchial Pressure in Long Term Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Peritoneal Dialysis
Arterial Sclerosis
Keywords: Arterial Stiffness
Pulse Wave Velocity
Peritoneal Dialysis
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 patients with end stage renal disease receiving peritoneal dialysis for more than 3 months.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years old or higher
2. Renal replacement therapy with Peritoneal Dialysis (Automated or Continuous Ambulatory) for at least 3 months prior to study enrollment
3. Patient to have provided informed written consent

Exclusion Criteria:

1. Ongoing atrial fibrillation
2. Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
3. Recent episode of PD-related peritonitis or exit site infection 1 month or less prior to study enrollment
4. Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used earlier for dialysis access in patients previously treated with hemodialysis
5. Body mass index (BMI) of \>40 kg/m2
6. History of malignancy or any other clinical condition associated with very poor prognosis

Primary outcomes:
measure: 24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity
timeFrame: 6 months
Secondary outcomes:
measure: 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity
timeFrame: 6 months
measure: Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity
timeFrame: 0, 6 months
measure: Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity
timeFrame: 6 months
measure: Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients
timeFrame: 0, 6 months
measure: The effect of overhydration on 24-hour ambulatory measurements
timeFrame: 0, 3, 6 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
affiliation: Department of Medicine, Aristotle University of Thessaloniki
name: Vassilios Liakopoulos, MD, PhD
role: STUDY_DIRECTOR
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