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Frequent Cuff Inflations May Disrupt the Accuracy of 24-hour Ambulatory Blood Pressure Monitoring

NCT04726761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 171

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Ambulatory Blood Pressure Monitoring, frequent/non-frequent

Patient will have a Spacelabs 90217 attached. This device can automatically measure the blood pressure over 24 hours. Patients will have their blood pressure measured first with a frequent interval, and then a non-frequent interval.

DIAGNOSTIC_TEST

Ambulatory Blood Pressure Monitoring, non-frequent/frequent

Patient will have a Spacelabs 90217 attached. This device can automatically measure the blood pressure over 24 hours. Patients will have their blood pressure measured first with a non-frequent interval, and then a frequent interval.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Henrik Buus · Klinisk Institut, Aarhus Universitets Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2022-01-31
Completion
2022-06-28

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04726761 on ClinicalTrials.gov