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

NCT04726761 | Completed

• 1 other identifier: 1337
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Ambulatory Blood Pressure Monitoring; ABPM

Outcome Measures

Primary Outcomes (1)

• The difference in mean systolic blood pressure (SBP) between 24-hour ABPM with frequent and non-frequent measurement intervals

  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.

  One week

Secondary Outcomes (3)

• 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

• The difference in average real variability (ARV), dipping status and morning surge during frequent and non-frequent measurement ABPM.

  One week

Study Arms (2)

Frequent/Non-frequent

Patients randomized to this order will first have an ABPM conducted with the frequent measuring intervals (3 times an hour during day and 2 times an hour at night) and then a few days later have another ABPM conducted with the non-frequent measuring interval (1 time an hour during all 24 hours)

Diagnostic Test: Ambulatory Blood Pressure Monitoring, frequent/non-frequent

Non-frequent/frequent

Patients randomized to this order will first have an ABPM conducted with the non-frequent measuring interval (1 time an hour during all 24 hours) and then a few days later have another ABPM conducted with the frequent measuring intervals (3 times an hour during day and 2 times an hour at night)

Diagnostic Test: Ambulatory Blood Pressure Monitoring, non-frequent/frequent

Interventions

Ambulatory Blood Pressure Monitoring, frequent/non-frequent DIAGNOSTIC_TEST

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.

Frequent/Non-frequent

Ambulatory Blood Pressure Monitoring, non-frequent/frequent DIAGNOSTIC_TEST

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.

Non-frequent/frequent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients, either referred or existing patients, who has to undergo a 24-hour ambulatory blood pressure monitoring

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Hypertension Clinic, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Niels Henrik Buus

  Klinisk Institut, Aarhus Universitets Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: March 2, 2021
• Primary Completion: January 31, 2022
• Study Completion: June 28, 2022
• Last Updated: June 30, 2022

Record last verified: 2021-01

Locations

DK (1)