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 hypertensio
- Conditions
- Hypertension
- Registration Number
- NL-OMON29341
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameters are twofold: <br>(1) Mean difference between HBPM and ABPM values calculated with the Bland-Altman method <br>(2) Mean standard deviation (SD) of the mean difference between HBPM and ABPM calculated with the Bland-Altman method. <br>- Both expressed in mmHg for both SBP and DBP<br>- The HBPM value is composed of a 7-day average of systolic and diastolic BP <br>- The ABPM value is composed of the average BP calculated by 24-hour ambulatory measurements
- Secondary Outcome Measures
Name Time Method