Hypertension High blood pressure
Conditions
Interventions
Cuffless blood pressure monitoring Hilo bracelet
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 antihypertensive medication, diagnosis hypertension is sufficient) 4. SBP>90 and 60 and
Exclusion criteria
Exclusion criteria: 1. SBP >180 mmHg and/or DBP >110mmHg at inclusion screening visit (measured by attended OBP method). 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 (for example benign prostate hypertrophy). 5. Unstable or uncontrolled endocrine disease (e.g. thyroid disease, Cushing*s or Addison*s disease) with the exception of diabetes mellitus. 6. Arrhythmias that prevent any BP measurement device to correctly measure BP during inclusion screening visit; such as supraventricular arrhythmias or atrial ventricular block. Known arrhythmias, but not clinically 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 highly suspected medication non-adherence by treating physician, proven direct observed therapy effect in BP). 10. Participants cannot plan a measurement schedule with a minimum of 22 and a maximum of 31-day period participation or a minimum of 4 and maximum of 5 hospital visits due to logistical issues or scheduling issues of any kind. 11. Physical inability to perform an home BP measurement. 12. Active pregnancy or planning trying to get pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint are twofold: 1. Mean differences in systolic blood pressure (SBP) and diastolic blood pressure (DBP) between cuffless BP monitoring and ABPM values. 2. Standard deviations of the mean differences between cuffless BP monitoring, ABPM, oscillometric HBPM, a-OBP and u-OBP | — |
Secondary
| Measure | Time frame |
|---|---|
| For all of the secondary objectives formulated in chapter 2 the study parameters are the same as the main study parameters. Other study variables that will be recorded for each study participant: Age, gender, arm circumference, medical history, BMI, medication use, and smoking behavior. | — |
Countries
Netherlands
Contacts
Public ContactW. Spiering
Universitair Medisch Centrum Utrecht
Outcome results
None listed