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Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

NCT ID: NCT04307004

Last Updated: 2024-12-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

654 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2022-12-13

Brief Summary

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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

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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.

Conditions

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Blood Pressure

Keywords

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Ambulatory blood pressure monitoring Home blood pressure monitoring Clinic blood pressure Blood pressure phenotypes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Unattended blood pressure measurement

Intervention Type OTHER

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

Intervention Type OTHER

Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room.

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.

Group Type OTHER

Ambulatory blood pressure monitoring

Intervention Type OTHER

Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.

Home blood pressure monitoring

Intervention Type OTHER

Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Ambulatory blood pressure monitoring

Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Microlife WatchBP Office AFIB Microlife WatchBP Office AFIB Microlife WatchBP O3 Microlife WatchBP Home N

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Emily B. Levitan

Professor and Vice Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Muntner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham Hypertension Research Clinic

Birmingham, Alabama, United States

Site Status

Columbia University Medical Center - Hypertension Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35667722 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R01HL139716

Identifier Type: NIH

Identifier Source: secondary_id

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5R01HL139716-02

Identifier Type: NIH

Identifier Source: org_study_id

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