Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

NCT04307004 | Completed Results

• 2 other identifiers: 5R01HL139716-02R01HL139716
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 2

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.

Conditions

Blood Pressure

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Left Ventricular Mass Index

  3 days

• Urinary Albumin-to-creatine Ratio

  3 days

Study Arms (2)

Unattended vs Attended Blood Pressure

OTHER

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; Other: Attended blood pressure measurement

ABPM vs HBPM

OTHER

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; Other: Home blood pressure monitoring

Interventions

Unattended blood pressure measurement OTHER

Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room.

Also known as: Microlife WatchBP Office AFIB

Unattended vs Attended Blood Pressure

Attended blood pressure measurement OTHER

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

Also known as: Microlife WatchBP Office AFIB

Unattended vs Attended Blood Pressure

Ambulatory blood pressure monitoring OTHER

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

Also known as: Microlife WatchBP O3

ABPM vs HBPM

Home blood pressure monitoring OTHER

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

Also known as: Microlife WatchBP Home N

ABPM vs HBPM

Eligibility Criteria

• Age: 19 Years - 87 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Columbia University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Alabama at Birmingham Hypertension Research Clinic

Birmingham, Alabama, 35205, United States

Location

Columbia University Medical Center - Hypertension Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 35667722 DERIVED

Results Point of Contact

• Title: Emily B. Levitan, Professor and Vice Chair
• Organization: University of Alabama at Birmingham

elevitan@uab.edu

(205) 975-7680

Study Officials

• Paul Muntner, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 13, 2020
• Study Start: July 15, 2019
• Primary Completion: December 12, 2022
• Study Completion: December 13, 2022
• Last Updated: December 13, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)