Trial Outcomes & Findings for Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure (NCT NCT04307004)

NCT ID: NCT04307004

Last Updated: 2024-12-13

Results Overview

The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 654 participants
• Primary outcome timeframe: 2 days
• Results posted on: 2024-12-13

Participant Flow

This study enrolled participants whose systolic and diastolic blood pressure were 110 mm Hg to < 160 mm Hg and 70 mm Hg to <100 mm Hg, respectively, during screening. Participants were enrolled from a hypertension research clinic at the University of Alabama at Birmingham and a hypertension center at the Columbia University Medical Center. The first participant was enrolled on 7/15/2019 and the last participant was enrolled in 11/28/2022.

Of the 1,095 participants screened, 654 met the inclusion criteria and were randomized to either attended (technician present) before unattended (technician absent) blood pressure measurements or unattended before attended blood pressure measurements. The 654 participants were also randomized to undergo either Ambulatory Blood Pressure Monitoring before Home Blood Pressure Monitoring or Home Blood Pressure Monitoring before Ambulatory Blood Pressure Monitoring.

Participant milestones

Measure	Attended Before Unattended BP During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended.	Unattended Before Attended BP During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended.	Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM) During visit 2, participants underwent 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) before undergoing one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) in visit 3.	Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM) During visit 2, participants underwent one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) before undergoing 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) in visit 3.
Randomization 1 STARTED	326	328	0	0
Randomization 1 COMPLETED	301	302	0	0
Randomization 1 NOT COMPLETED	25	26	0	0
Randomization 2 STARTED	0	0	330	324
Randomization 2 COMPLETED	0	0	302	301
Randomization 2 NOT COMPLETED	0	0	28	23

Reasons for withdrawal

Measure	Attended Before Unattended BP During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended.	Unattended Before Attended BP During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended.	Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM) During visit 2, participants underwent 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) before undergoing one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) in visit 3.	Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM) During visit 2, participants underwent one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) before undergoing 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) in visit 3.
Randomization 1 Withdrawal by Subject	25	26	0	0
Randomization 2 Withdrawal by Subject	0	0	28	23

Baseline Characteristics

Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

Baseline characteristics by cohort

Measure	Attended Before Unattended BP n=301 Participants During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended.	Unattended Before Attended BP n=302 Participants During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended.	Total n=603 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 16.0 • n=5 Participants	37.9 years STANDARD_DEVIATION 14.1 • n=7 Participants	38.6 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	192 Participants n=7 Participants	382 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	110 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	29 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	259 Participants n=5 Participants	272 Participants n=7 Participants	531 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	39 Participants n=5 Participants	51 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	64 Participants n=5 Participants	68 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants	141 Participants n=7 Participants	291 Participants n=5 Participants
Race (NIH/OMB) More than one race	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants	20 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	301 Participants n=5 Participants	302 Participants n=7 Participants	603 Participants n=5 Participants
Body Mass Index	26.8 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants	27.5 kg/m^2 STANDARD_DEVIATION 5.8 • n=7 Participants	27.2 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants
Self-reported Hypertension	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Sel-reported High Cholesterol	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Sef-reported Diabetes	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Self-reported Asthma or Hey Fever	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Participants with complete attended and unattended blood pressure data.

The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.

Outcome measures

Measure	Attended Clinic Systolic Blood Pressure n=603 Participants Systolic blood pressure collected by a clinic technician.	Attended Clinic Diastolic Blood Pressure n=603 Participants Diastolic blood pressure collected by a clinic technician.	Unattended Clinic Systolic Blood Pressure n=603 Participants Systolic blood pressure collected automatically in the clinic without a technician present.	Unattended Clinic Diastolic Blood Pressure n=603 Participants Diastolic blood pressure collected automatically in the clinic without a technician present.
Absolute Difference Between Unattended and Attended Blood Pressure	119.5 mm Hg Standard Deviation 12.1	72.7 mm Hg Standard Deviation 7.8	118.7 mm Hg Standard Deviation 11.8	72.2 mm Hg Standard Deviation 7.7

PRIMARY outcome

Timeframe: 2 days

Population: Participants with complete ambulatory and home blood pressure monitoring data.

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.

Outcome measures

Measure	Attended Clinic Systolic Blood Pressure n=547 Participants Systolic blood pressure collected by a clinic technician.	Attended Clinic Diastolic Blood Pressure n=547 Participants Diastolic blood pressure collected by a clinic technician.	Unattended Clinic Systolic Blood Pressure n=547 Participants Systolic blood pressure collected automatically in the clinic without a technician present.	Unattended Clinic Diastolic Blood Pressure n=547 Participants Diastolic blood pressure collected automatically in the clinic without a technician present.
Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor	104.1 mm Hg Standard Deviation 10.5	60.4 mm Hg Standard Deviation 7.5	106.4 mm Hg Standard Deviation 11.5	62.3 mm Hg Standard Deviation 8.3

PRIMARY outcome

Timeframe: 3 days

Population: Participants who completed questionnaires regarding their experiences wearing both the ambulatory and home blood pressure monitors.

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.

Outcome measures

Measure	Attended Clinic Systolic Blood Pressure n=603 Participants Systolic blood pressure collected by a clinic technician.	Attended Clinic Diastolic Blood Pressure n=603 Participants Diastolic blood pressure collected by a clinic technician.	Unattended Clinic Systolic Blood Pressure Systolic blood pressure collected automatically in the clinic without a technician present.	Unattended Clinic Diastolic Blood Pressure Diastolic blood pressure collected automatically in the clinic without a technician present.
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Pain while wearing the monitor	288 Participants	165 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Irritation while wearing the monitor	410 Participants	258 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Bruising while wearing the monitor	138 Participants	73 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Monitor was heavy to wear	272 Participants	186 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Monitor was uncomfortable to wear	508 Participants	467 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Monitor was straightforward to use	590 Participants	584 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Monitor was cumbersome or awkward to wear	507 Participants	404 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Noise of the monitor was disturbing to me	193 Participants	173 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Noise of the monitor disturb others	110 Participants	67 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Monitor was embarrassing to wear	305 Participants	103 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Monitor interfered with normal sleeping pattern	343 Participants	275 Participants	—	—
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires Removed monitor due to disturbance while sleeping	39 Participants	39 Participants	—	—

SECONDARY outcome

Timeframe: 3 days

Mean left ventricular mass index (LVMI)

Outcome measures

Measure	Attended Clinic Systolic Blood Pressure n=301 Participants Systolic blood pressure collected by a clinic technician.	Attended Clinic Diastolic Blood Pressure n=302 Participants Diastolic blood pressure collected by a clinic technician.	Unattended Clinic Systolic Blood Pressure n=302 Participants Systolic blood pressure collected automatically in the clinic without a technician present.	Unattended Clinic Diastolic Blood Pressure n=301 Participants Diastolic blood pressure collected automatically in the clinic without a technician present.
Left Ventricular Mass Index	67.6 g/m^2 Standard Deviation 18.1	67.1 g/m^2 Standard Deviation 16.9	66.9 g/m^2 Standard Deviation 17.4	67.7 g/m^2 Standard Deviation 17.5

SECONDARY outcome

Timeframe: 3 days

Mean urinary albumin-to-creatinine ratio (UACR)

Outcome measures

Measure	Attended Clinic Systolic Blood Pressure n=301 Participants Systolic blood pressure collected by a clinic technician.	Attended Clinic Diastolic Blood Pressure n=302 Participants Diastolic blood pressure collected by a clinic technician.	Unattended Clinic Systolic Blood Pressure n=302 Participants Systolic blood pressure collected automatically in the clinic without a technician present.	Unattended Clinic Diastolic Blood Pressure n=301 Participants Diastolic blood pressure collected automatically in the clinic without a technician present.
Urinary Albumin-to-creatine Ratio	21.7 mg/g Standard Deviation 51.5	17.0 mg/g Standard Deviation 21.6	19.7 mg/g Standard Deviation 35.9	18.9 mg/g Standard Deviation 43.0

Adverse Events

Attended Before Unattended BP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unattended Before Attended BP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM)

Serious events: 0 serious events

Other events: 228 other events

Deaths: 0 deaths

Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM)

Serious events: 0 serious events

Other events: 244 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Attended Before Unattended BP n=326 participants at risk During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended.	Unattended Before Attended BP n=328 participants at risk During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended.	Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM) n=330 participants at risk During visit 2, participants underwent 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) before undergoing one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) in visit 3.	Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM) n=324 participants at risk During visit 2, participants underwent one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) before undergoing 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) in visit 3.
Skin and subcutaneous tissue disorders Brusing	0.00% 0/326 • 2 weeks.	0.00% 0/328 • 2 weeks.	7.9% 26/330 • 2 weeks.	8.3% 27/324 • 2 weeks.
Skin and subcutaneous tissue disorders Pain	0.00% 0/326 • 2 weeks.	0.00% 0/328 • 2 weeks.	18.5% 61/330 • 2 weeks.	20.4% 66/324 • 2 weeks.
Skin and subcutaneous tissue disorders Irritation	0.00% 0/326 • 2 weeks.	0.00% 0/328 • 2 weeks.	33.0% 109/330 • 2 weeks.	37.7% 122/324 • 2 weeks.
Skin and subcutaneous tissue disorders Discomfort	0.00% 0/326 • 2 weeks.	0.00% 0/328 • 2 weeks.	57.6% 190/330 • 2 weeks.	64.2% 208/324 • 2 weeks.
Skin and subcutaneous tissue disorders Heavy to wear monitor	0.00% 0/326 • 2 weeks.	0.00% 0/328 • 2 weeks.	22.1% 73/330 • 2 weeks.	20.1% 65/324 • 2 weeks.

Additional Information

Emily B. Levitan, Professor and Vice Chair

University of Alabama at Birmingham

Phone: (205) 975-7680

Email: elevitan@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place