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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity | 24-hour ambulatory Branchial vs office Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity | 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period | 6 months |
| Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity |
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Inclusion Criteria:
Exclusion Criteria:
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40 patients with end stage renal disease receiving peritoneal dialysis for more than 3 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasileios Vaios, MD | Contact | +306984568904 | vvaios_85@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Vassilios Liakopoulos, MD, PhD | Department of Medicine, Aristotle University of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | Recruiting | Thessaloniki | 54621 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15385656 | Background | 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. | |
| 16738019 | Background | Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006 Jul;17(7):2034-47. doi: 10.1681/ASN.2005101085. Epub 2006 May 31. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001161 | Arteriosclerosis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Assessing the correlation between the short-term variability of 24-hour ambulatory Branchial and Aortic SBP with the changes in Pulse Wave Velocity at the start of the study and over a 6 month period |
| 0, 6 months |
| Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity | Assessing the predictive value of visit-to-visit variability of Branchial SBP for the changes in Pulse Wave Velocity over a 6 month period | 6 months |
| Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients | Assessing whether or not office blood pressure measurements can diagnose hypertension or control of hypertension, based on the 24-hour ambulatory recordings | 0, 6 months |
| The effect of overhydration on 24-hour ambulatory measurements | The correlation between overhydration (defined by the measurement of fluid status using Bioelectrical Impendence Analysis) and the 24-hour ambulatory Aortic and Branchial SBP measurements at the start of the study and over a 6 month period | 0, 3, 6 months |
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| 16476843 | Background | Williams B, Lacy PS, Thom SM, Cruickshank K, Stanton A, Collier D, Hughes AD, Thurston H, O'Rourke M; CAFE Investigators; Anglo-Scandinavian Cardiac Outcomes Trial Investigators; CAFE Steering Committee and Writing Committee. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006 Mar 7;113(9):1213-25. doi: 10.1161/CIRCULATIONAHA.105.595496. Epub 2006 Feb 13. |
| 22673021 | Background | Protogerou AD, Argyris A, Nasothimiou E, Vrachatis D, Papaioannou TG, Tzamouranis D, Blacher J, Safar ME, Sfikakis P, Stergiou GS. Feasibility and reproducibility of noninvasive 24-h ambulatory aortic blood pressure monitoring with a brachial cuff-based oscillometric device. Am J Hypertens. 2012 Aug;25(8):876-82. doi: 10.1038/ajh.2012.63. Epub 2012 Jun 7. |
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| 25322847 | Background | Sarafidis PA, Georgianos PI, Karpetas A, Bikos A, Korelidou L, Tersi M, Divanis D, Tzanis G, Mavromatidis K, Liakopoulos V, Zebekakis PE, Lasaridis A, Protogerou AD. Evaluation of a novel brachial cuff-based oscillometric method for estimating central systolic pressure in hemodialysis patients. Am J Nephrol. 2014;40(3):242-50. doi: 10.1159/000367791. Epub 2014 Oct 11. |
| 23817082 | Background | Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available. |
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| 11729246 | Background | London GM, Pannier B, Guerin AP, Blacher J, Marchais SJ, Darne B, Metivier F, Adda H, Safar ME. Alterations of left ventricular hypertrophy in and survival of patients receiving hemodialysis: follow-up of an interventional study. J Am Soc Nephrol. 2001 Dec;12(12):2759-2767. doi: 10.1681/ASN.V12122759. |
| 35882382 | Derived | Vareta G, Georgianos PI, Vaios V, Sgouropoulou V, Georgianou EI, Leivaditis K, Mavromatidis K, Dounousi E, Papagianni A, Balaskas EV, Zebekakis PE, Liakopoulos V. Prevalence of Apparent Treatment-Resistant Hypertension in ESKD Patients Receiving Peritoneal Dialysis. Am J Hypertens. 2022 Nov 2;35(11):918-922. doi: 10.1093/ajh/hpac086. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |