Frequent Cuff Inflations May Disrupt the Accuracy of 24-hour Ambulatory Blood Pressure Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- The difference in mean systolic blood pressure (SBP) between 24-hour ABPM with frequent and non-frequent measurement intervals
Study Overview
Brief Summary
24-hour ambulatory blood pressure monitoring (ABPM) is superior to office blood pressure (BP) for assessing cardiovascular risk. On the other hand, repeated cuff inflations during ABPM can cause discomfort and reduced quality of sleep. A high frequency of measurement during ABPM might result in erroneously high BP measurement, incorrect hypertension diagnoses, unnecessary treatment or just overtreatment with antihypertensive medication and potentially serious side effects.
The purpose of this study is to investigate whether the frequency of measurements during ABPM impacts the measured BP during ABPM.
Patients will be recruited from the Clinic of Hypertension at Aarhus University Hospital, Denmark. The study will be conducted as a randomized controlled crossover study. Participants will undergo two 24-hour ABPMs: One with a low frequency of measurement, 1-time per hour during the day and 1-time per hour during the night, and one with a high frequency, 3-times/hour during the day, and 2-times/hour at night. The primary endpoint will be the difference in 24-hour mean systolic BP between the high- and low frequency measurement ABPM.
Detailed Description
Aim:
The purpose of this study is to evaluate if 24-hour ABPM with frequent BP measurements (intervals of 20 minutes during daytime and 30 minutes during nighttime) result in erroneously elevated BP in hypertensive patients compared with non-frequent BP readings (measurement intervals of 60 minutes both day and night).
Population:
The study population will comprise all patients referred to and attending the Clinic of Hypertension, AUH, who are scheduled to undergo ABPM. At referral to the Clinic of Hypertension, AUH, patients will be contacted with an electronic or analog letter, informing them about the study and inviting them to participate. Patients who already are being treated at the Clinic of Hypertension, will be invited at an appointment in the clinic. Patients will be excluded from the study if they have atrial fibrillation, nighttime work, insomnia or sleeping disorders, and are not physically able to undergo an ABPM (e.g. too big arm circumference to fit the cuff).
Methods:
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients either has to be referred from primary care to the Clinic of Hypertension at Aarhus University hospital, or already being treated at the clinic. Both groups has to be scheduled for a 24-hour ambulatory blood pressure monitoring.
Exclusion Criteria
- •Below 18 years of age
- •Have atrial fibrillation
- •Have routine nightshift work
- •Is pregnant
- •Is physically inable to have the cuff applied correctly (too large arm circumference)
- •Known insomnia or other sleeping disorders
- •Change in blood pressure medication within 14 days before inclusion
Outcomes
Primary Outcomes
The difference in mean systolic blood pressure (SBP) between 24-hour ABPM with frequent and non-frequent measurement intervals
Time Frame: One week
The systolic blood pressure is one of the most important predictors of a patient's risk of cardiovascular disease that can be measured with ABPM.
Secondary Outcomes
- The difference in average real variability (ARV), dipping status and morning surge during frequent and non-frequent measurement ABPM.(One week)
- The difference in mean diastolic blood pressure (DBP) between 24-hour ABPM with frequent and non-frequent measurement intervals.(One week)
- The self-reported pain/discomfort, interference in daily life, and disturbance of sleep during frequent and non-frequent measurement ABPM(One week)