跳至主要内容
临床试验/NCT03306160
NCT03306160Unknown不适用

Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis: the C-HEMO Study

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2017年10月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
900
试验地点
1
主要终点
cardiovascular deaths

研究概览

简要总结

This is a prospective cohort study which aims to explore the significance of brachial and central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients with end stage renal disease who are treated with hemodialysis. Enrolled patients will receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time dialysis after enrollment. And their cardiovascular events and deaths at first and third year will be followed-up.

详细描述

The protocol of this study was approved by the local ethical review board. The including criteria: 1) ESRD treated with hemodialysis for more than 3 months prior to study enrollment; 2) agree to participate the study and sign informed written consent; 3) available for long-term follow-up. The excluding criteria: 1)chronic atrial fibrillation or other cardiac arrhythmia; 2) nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis; 3) myocardial infarction, angina pectoris and ischemic stroke during the previous month; 4) congestive heart failure class IV based on the New York Heart Association classification; 5) malignancy or any other condition with poor prognosis; 6) antihypertensive treatment during one month prior to enrollment. After enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight; biochemical tests including vein blood and urine. At the first-time dialysis after enrollment, patients will receive 48-hour central and brachial ambulatory blood pressure monitoring using a well validated and commercial device Mobil-O-Graph (IEM, Germany). Brachial blood pressure are measured for each patient before every dialysis for at three month. Then one-year and three-year cardiovascular events and deaths will be followed-up. The primary outcome measures are as follows: deaths and cardiovascular events including nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with end-stage renal disease treated with hemodialysis for more than 3 months prior to study enrollment;
  • agree to participate the study and sign informed written consent;
  • available for long-term follow-up.

排除标准

  • chronic atrial fibrillation or other cardiac arrhythmia;
  • nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis;
  • myocardial infarction, angina pectoris and ischemic stroke during the previous month;
  • congestive heart failure class IV based on the New York Heart Association classification;
  • malignancy or any other condition with poor prognosis;
  • antihypertensive treatment during 1 month prior to enrollment.

结局指标

主要结局

cardiovascular deaths

时间窗: 3 year

cardiovascular deaths

Cardiovascular events

时间窗: 3 year

nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest

all-cause deaths

时间窗: 3 year

all-cause deaths

次要结局

未报告次要终点

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

The chief director of department of cardiology

Shanghai 10th People's Hospital

研究点 (1)

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