Longitudinal Change of Arterial Stiffness Indices in Relation to Ambulatory Aortic and Branchial Pressure in Long Term Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or higher
- •Renal replacement therapy with Peritoneal Dialysis (Automated or Continuous Ambulatory) for at least 3 months prior to study enrollment
- •Patient to have provided informed written consent
排除标准
- •Ongoing atrial fibrillation
- •Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
- •Recent episode of PD-related peritonitis or exit site infection 1 month or less prior to study enrollment
- •Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used earlier for dialysis access in patients previously treated with hemodialysis
- •Body mass index (BMI) of >40 kg/m2
- •History of malignancy or any other clinical condition associated with very poor prognosis
结局指标
主要结局
24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity
时间窗: 6 months
24-hour ambulatory Branchial vs office Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period
次要结局
- 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity(6 months)
- Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients(0, 6 months)
- Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity(0, 6 months)
- The effect of overhydration on 24-hour ambulatory measurements(0, 3, 6 months)
- Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity(6 months)
研究者
Vaios Vasileios
Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital
Aristotle University Of Thessaloniki