Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- 1-hour blood pressure monitoring
研究概览
简要总结
Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.
Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •To visit routinely in the health centres where the study is carried out
排除标准
- •Severe physical or cognitive limitations
- •Atrial fibrillation or other heart rhythm disorders that could interfere with readings
- •Arm Circumference > 42cm
- •Arm with arteriovenous fistula
- •Mental disorders
- •Intolerance to the method of measurement
- •Hospitalization during the study period
结局指标
主要结局
1-hour blood pressure monitoring
时间窗: Assessed at 1 study visit (1 hour)
Blood pressure measurements obtained by 1-hour blood pressure monitoring
24-hour ambulatory blood pressure monitoring
时间窗: Assessed at 1 day
Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring
Office blood pressure measurement
时间窗: Assessed at 3 study visits in two weeks
Blood pressure measurements obtained by office blood pressure measurement
Home blood pressure monitoring
时间窗: Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven
Blood pressure measurements obtained by home blood pressure monitoring
次要结局
未报告次要终点
研究者
Dr. Antoni Siso Almirall
Head of Research
Consorci d'Atenció Primària de Salut de l'Eixample
