Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study

The purpose of the proposed study is to test whether measuring unattended blood pressure using an automated blood pressure monitor in a clinic setting without staff being present can reduce the need for assessing out-of- clinic awake blood pressure using ambulatory monitoring. Also, the investigators will test whether asleep blood pressure can be accurately measured using a novel home blood pressure monitoring device with less burden compared with ambulatory monitoring.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Unattended blood pressure measurement; Other: Attended blood pressure measurement; Other: Ambulatory blood pressure monitoring; Other: Home blood pressure monitoring

Detailed Description

For many people, blood pressure levels differ when measured in a doctor's office versus during normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves wearing a blood pressure cuff attached to a device that is programmed to measure participants blood pressure every 30 minutes for a 24-hour period. ABPM can help better estimate a person's true average blood pressure. Although ABPM is recommended for diagnosing high blood pressure and it also measures blood pressure while people sleep, it is not available in many clinics and some people find the procedure to be uncomfortable. The purpose of this research study is to test whether blood pressure measured in a clinic setting without medical staff present is comparable to blood pressure levels measured during the daytime measured using an ABPM device. Also, the investigators will test whether asleep blood pressure can be accurately measured using a home blood pressure monitoring device. These findings may help identify new approaches for diagnosing high blood pressure without the need for ABPM. Each participant will complete four study visits. During the course of the study, participants will:

• Have their blood pressure measured in the clinic, six times at each of the first two study visits for a total of twelve blood pressure measurements.
• Complete questionnaires about their demographics, medical history, and participant sleeping habits.
• Have their blood drawn and provide a urine sample.
• Wear a Food and Drug Administration-approved ABPM device (Microlife WatchBP O3) for 24 hours.
• Wear a Food and Drug Administration-approved home blood pressure monitor (Microlife WatchBP Home N) while they sleep for one night.
• Wear an activity monitor (Actiwatch) for two 24-hour periods. The Actiwatch activity monitor measures activity levels and can be used to identify when they are asleep.
• Answer some questions about their experience while wearing the ABPM and home blood pressure monitor.
• Have an echocardiogram performed.

• Study Type: Interventional
• Enrollment (Actual): 654
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • University of Alabama at Birmingham Hypertension Research Clinic
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center - Hypertension Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit
• Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit

Exclusion Criteria:

• Currently taking antihypertensive medications
• Known to be currently pregnant
• History of sleep apnea
• History of heart attack, stroke, or any cardiovascular disease
• History of arrhythmia (e.g. - atrial fibrillation or ventricular tachycardia)
• Completed ambulatory blood pressure monitoring in the past year
• Second shift, overnight, or jobs that will not allow ambulatory blood pressure device to measure every 30 minutes for 24 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ABPM vs HBPM; Participants will be fitted with either the Microlife WatchBP O3 ambulatory blood pressure monitoring device or instructed on how to use the Microlife WatchBP Home N home blood pressure device, depending on which they are assigned to complete first. The order in which participants undergo ambulatory or home blood pressure monitoring will be assigned through a random number generator.	Other: Ambulatory blood pressure monitoring; Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.; Other Names: Microlife WatchBP O3; Other: Home blood pressure monitoring; Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.; Other Names: Microlife WatchBP Home N
Other: Unattended vs Attended Blood Pressure; Participants blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device. Whether investigators measure blood pressure attended first and then unattended or unattended first and then attended will be assigned using a random number generator. At visit 2, clinic blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device, as at visit 1, but in the reverse order.	Other: Unattended blood pressure measurement; Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room.; Other Names: Microlife WatchBP Office AFIB; Other: Attended blood pressure measurement; Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room.; Other Names: Microlife WatchBP Office AFIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Difference Between Unattended and Attended Blood Pressure	The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.	2 days
Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor	Participants will have their systolic and diastolic blood pressure measured overnight using a home blood pressure monitor and over 24-hours using an ambulatory blood pressure monitor.	2 days
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires	Participants will complete questionnaires regarding their experience wearing both the ambulatory and home blood pressure monitors as well as a questionnaire on their willingness to wear the devices again.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Mass Index	Mean left ventricular mass index (LVMI)	3 days
Urinary Albumin-to-creatine Ratio	Mean urinary albumin-to-creatinine ratio (UACR)	3 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Columbia University
• Investigators: Principal Investigator: Paul Muntner, PhD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Cepeda M, Hubbard D, Oparil S, Schwartz JE, Jaeger BC, Hardy ST, Medina J, Chen L, Muntner P, Shimbo D. Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial. BMJ Open. 2022 Jun 6;12(6):e058140. doi: 10.1136/bmjopen-2021-058140.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Ambulatory blood pressure monitoring; Home blood pressure monitoring; Clinic blood pressure; Blood pressure phenotypes
• Other Study ID Numbers: 5R01HL139716-02 (U.S. NIH Grant/Contract); R01HL139716 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No