Clinical trial NCT04307004: Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
Official title: Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Ambulatory blood pressure monitoring
Home blood pressure monitoring
Clinic blood pressure
Blood pressure phenotypes
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Columbia University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-03-13
Enrollment: 654
Sex: ALL
Minimum age (years): 19
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Difference Between Unattended and Attended Blood Pressure
timeFrame: 2 days
measure: Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor
timeFrame: 2 days
measure: Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires
timeFrame: 3 days
Secondary outcomes:
measure: Left Ventricular Mass Index
timeFrame: 3 days
measure: Urinary Albumin-to-creatine Ratio
timeFrame: 3 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hypertension Research Clinic
state: Alabama
city: New York
country: United States
facility: Columbia University Medical Center - Hypertension Center
state: New York
Study officials:
affiliation: University of Alabama at Birmingham
name: Paul Muntner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.