Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307004
• Other study ID #: 5R01HL139716-02
• Secondary ID: R01HL139716
• Status: Completed
• Phase: N/A
• Start date: July 2, 2019
• Est. completion date: December 28, 2022

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: December 28, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 87 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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.
• 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.
• Ambulatory blood pressure monitoring
Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.
• Home blood pressure monitoring
Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Hypertension Research Clinic	Birmingham	Alabama
United States	Columbia University Medical Center - Hypertension Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Columbia University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Correlation between different blood pressure measurements and LVMI	Assess the correlation between unattended versus attended clinic BP, unattended clinic BP versus awake BP on ABPM, and sleep BP on HBPM versus ABPM with left ventricular mass index (LVMI) (g/m^2).	3 days
Secondary	Correlation between different blood pressure measurements and ACR	Assess the correlation between unattended versus attended clinic BP, unattended clinic BP versus awake BP on ABPM, and sleep BP on HBPM versus ABPM with albumin-to-creatinine ratio (ACR) (mg/g).	3 days