NL-OMON29341尚未招募不适用
A randomized cross-over study to investigate the agreement betwen 24-hour ambulant blood pressure monitoring, home blood pressure monitoring, unattended&attended automated office and 30-minute blood pressure monitoring, unattended & attended automated office and 30-minute blood pressure measurment in patients treated for hypertension
MC Utrecht0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational non invasive
入排标准
入选标准
- •1. Age of 18 years or older
- •2. Documented medical history of hypertension in local hospital electronic patient record
- •3. Stable dose of anti-hypertensive medication for at least 2 months (includes no current antihypertensivemedication, diagnosis hypertension is enough)
- •4. SBP>90 and <180 mmHg and DBP >60 and <110mmHg at inclusion screening attained by attended office blood pressure measurement
- •5. Dutch and/or English language capable for reading patient information letter and in-app instructions.
- •6. Smartphone or tablet owner with either iOS or Android installed as operating system. Operating systemrequirements: iOS 8.0 or higher, Android version 4.1 or higher
排除标准
- •1. SBP >180 mmHg and/or DBP >110mmHg at inclusion screening visit (attended AOBP).
- •2. Any BP that according to the treating physician is not adequately controlled and needs medication adjustment <2 months or within the study time period.
- •3. Recent (<2 months) anti-hypertensive medication changes (including diuretics).
- •4. Recent start or change in dosing of alpha-blockers prescribed for other purpose than blood pressure control (forexample benign prostate hypertrophy).
- •5. Unstable or uncontrolled endocrine disease (e.g. thyroid disease, Cushing’s or Addison’s disease) with theexception of diabetes mellitus.
- •6. Persistend arrhythmias that prevent any BP measurement device to correctly measure BP during inclusionscreening visit; such as supraventricular arrhythmias or atrial ventricular block. Known arrhythmias, but notclinically present during inclusion screening is not an exclusion criterion.
- •7. Heart failure grade 2 or higher on the New York Heart Association (NYHA) Functional Classification.
- •8. Documented missed outpatient clinic appointments (2 or more the last 6 months).
- •9. Documented therapy non-adherence (e.g. biochemical proven medication non-adherence, known or highlysuspected medication non-adherence by treating physician, proven direct observed therapy effect in BP).
- •10. Participants cannot plan a measurement schedule with a minimum of 21 and a maximum of 29-day periodparticipation or a minimum of 4 and maximum of 5 hospital visits due to logistical issues or scheduling issues ofany kind.
- •11. Physical inability to perform an home BP measurement, use the Microlife A6 BT BP device and orMicrolife@Home app.
- •12. For Women: active pregnancy or planning trying to get pregnant during the study period
研究者
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