Blood Pressure
Conditions
Keywords
Ambulatory blood pressure monitoring, Home blood pressure monitoring, Clinic blood pressure, Blood pressure phenotypes
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.
Interventions
OTHERUnattended 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.
OTHERAttended 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.
Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.
Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.
Sponsors
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 87 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Difference Between Unattended and Attended Blood Pressure | 2 days | The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room. |
| Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor | 2 days | 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. |
| Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Mass Index | 3 days | Mean left ventricular mass index (LVMI) |
| Urinary Albumin-to-creatine Ratio | 3 days | Mean urinary albumin-to-creatinine ratio (UACR) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 301 |
| 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. | 302 |
| Total | 603 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Randomization 1 | Withdrawal by Subject | 25 | 26 | 0 | 0 |
| Randomization 2 | Withdrawal by Subject | 0 | 0 | 28 | 23 |
Baseline characteristics
| Characteristic | Attended Before Unattended BP | Total | Unattended Before Attended BP |
|---|---|---|---|
| Age, Continuous | 39.4 years STANDARD_DEVIATION 16 | 38.6 years STANDARD_DEVIATION 15.1 | 37.9 years STANDARD_DEVIATION 14.1 |
| Body Mass Index | 26.8 kg/m^2 STANDARD_DEVIATION 5.9 | 27.2 kg/m^2 STANDARD_DEVIATION 5.9 | 27.5 kg/m^2 STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 69 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 259 Participants | 531 Participants | 272 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 90 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants | 132 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 36 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants | 53 Participants | 20 Participants |
| Race (NIH/OMB) White | 150 Participants | 291 Participants | 141 Participants |
| Region of Enrollment United States | 301 Participants | 603 Participants | 302 Participants |
| Sef-reported Diabetes | 2 Participants | 10 Participants | 8 Participants |
| Self-reported Asthma or Hey Fever | 32 Participants | 68 Participants | 36 Participants |
| Self-reported Hypertension | 25 Participants | 40 Participants | 15 Participants |
| Sel-reported High Cholesterol | 28 Participants | 56 Participants | 28 Participants |
| Sex: Female, Male Female | 190 Participants | 382 Participants | 192 Participants |
| Sex: Female, Male Male | 111 Participants | 221 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 326 | 0 / 328 | 0 / 330 | 0 / 324 |
| other Total, other adverse events | 0 / 326 | 0 / 328 | 228 / 330 | 244 / 324 |
| serious Total, serious adverse events | 0 / 326 | 0 / 328 | 0 / 330 | 0 / 324 |
Outcome results
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.
Time frame: 2 days
Population: Participants with complete attended and unattended blood pressure data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attended Clinic Systolic Blood Pressure | Absolute Difference Between Unattended and Attended Blood Pressure | 119.5 mm Hg | Standard Deviation 12.1 |
| Attended Clinic Diastolic Blood Pressure | Absolute Difference Between Unattended and Attended Blood Pressure | 72.7 mm Hg | Standard Deviation 7.8 |
| Unattended Clinic Systolic Blood Pressure | Absolute Difference Between Unattended and Attended Blood Pressure | 118.7 mm Hg | Standard Deviation 11.8 |
| Unattended Clinic Diastolic Blood Pressure | Absolute Difference Between Unattended and Attended Blood Pressure | 72.2 mm Hg | Standard Deviation 7.7 |
p-value: <0.000195% CI: [0.5, 1.1]Paired T Test, 2-sided
p-value: <0.000195% CI: [0.3, 0.7]Paired T Test, 2-sided
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.
Time frame: 2 days
Population: Participants with complete ambulatory and home blood pressure monitoring data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attended Clinic Systolic Blood Pressure | 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 |
| Attended Clinic Diastolic Blood Pressure | Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor | 60.4 mm Hg | Standard Deviation 7.5 |
| Unattended Clinic Systolic Blood Pressure | Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor | 106.4 mm Hg | Standard Deviation 11.5 |
| Unattended Clinic Diastolic Blood Pressure | Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor | 62.3 mm Hg | Standard Deviation 8.3 |
p-value: <0.000195% CI: [-3, -1.5]Paired T Test, 2-sided
p-value: <0.000195% CI: [-2.5, -1.4]Paired T Test, 2-sided
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.
Time frame: 3 days
Population: Participants who completed questionnaires regarding their experiences wearing both the ambulatory and home blood pressure monitors.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Pain while wearing the monitor | 288 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Irritation while wearing the monitor | 410 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Bruising while wearing the monitor | 138 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was heavy to wear | 272 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was uncomfortable to wear | 508 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was straightforward to use | 590 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was cumbersome or awkward to wear | 507 Participants |
| Attended Clinic Systolic Blood Pressure | 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 |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Noise of the monitor disturb others | 110 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was embarrassing to wear | 305 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor interfered with normal sleeping pattern | 343 Participants |
| Attended Clinic Systolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Removed monitor due to disturbance while sleeping | 39 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor interfered with normal sleeping pattern | 275 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Pain while wearing the monitor | 165 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was cumbersome or awkward to wear | 404 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Irritation while wearing the monitor | 258 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was embarrassing to wear | 103 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Bruising while wearing the monitor | 73 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Noise of the monitor was disturbing to me | 173 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was heavy to wear | 186 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Removed monitor due to disturbance while sleeping | 39 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was uncomfortable to wear | 467 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Noise of the monitor disturb others | 67 Participants |
| Attended Clinic Diastolic Blood Pressure | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Monitor was straightforward to use | 584 Participants |
Secondary
Left Ventricular Mass Index
Mean left ventricular mass index (LVMI)
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attended Clinic Systolic Blood Pressure | Left Ventricular Mass Index | 67.6 g/m^2 | Standard Deviation 18.1 |
| Attended Clinic Diastolic Blood Pressure | Left Ventricular Mass Index | 67.1 g/m^2 | Standard Deviation 16.9 |
| Unattended Clinic Systolic Blood Pressure | Left Ventricular Mass Index | 66.9 g/m^2 | Standard Deviation 17.4 |
| Unattended Clinic Diastolic Blood Pressure | Left Ventricular Mass Index | 67.7 g/m^2 | Standard Deviation 17.5 |
Comparison: We determined the association between attended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.32, 0.55]Regression, Linear
Comparison: We determined the association between attended diastolic blood pressure measurements and left ventricular mass index (LVMI). This analysis included 587 with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.24, 0.6]Regression, Linear
Comparison: We determined the association between unattended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.33, 0.56]Regression, Linear
Comparison: We determined the association between unattended diastolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.19, 0.55]Regression, Linear
Comparison: We determined the association between awake systolic blood pressure from ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.47, 0.74]Regression, Linear
Comparison: We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.25, 0.66]Regression, Linear
Comparison: We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with HBPM data and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.19, 0.44]Regression, Linear
Comparison: We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on HBPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.0195% CI: [0.05, 0.4]Regression, Linear
Comparison: We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.32, 0.59]Regression, Linear
Comparison: We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: <0.00195% CI: [0.16, 0.55]Regression, Linear
Secondary
Urinary Albumin-to-creatine Ratio
Mean urinary albumin-to-creatinine ratio (UACR)
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attended Clinic Systolic Blood Pressure | Urinary Albumin-to-creatine Ratio | 21.7 mg/g | Standard Deviation 51.5 |
| Attended Clinic Diastolic Blood Pressure | Urinary Albumin-to-creatine Ratio | 17.0 mg/g | Standard Deviation 21.6 |
| Unattended Clinic Systolic Blood Pressure | Urinary Albumin-to-creatine Ratio | 19.7 mg/g | Standard Deviation 35.9 |
| Unattended Clinic Diastolic Blood Pressure | Urinary Albumin-to-creatine Ratio | 18.9 mg/g | Standard Deviation 43 |
Comparison: We determined the association between attended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.1795% CI: [-0.47, 0.08]Regression, Linear
Comparison: We determined the association between attended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.295% CI: [-0.7, 0.15]Regression, Linear
Comparison: We determined the association between unattended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.0795% CI: [-0.55, 0.02]Regression, Linear
Comparison: We determined the association between unattended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended diastolic blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.0995% CI: [-0.8, 0.06]Regression, Linear
Comparison: We determined the association between awake systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.9495% CI: [-0.29, 0.31]Regression, Linear
Comparison: We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.3195% CI: [-0.21, 0.66]Regression, Linear
Comparison: We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.9495% CI: [-0.28, 0.26]Regression, Linear
Comparison: We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.9395% CI: [-0.4, 0.36]Regression, Linear
Comparison: We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.5495% CI: [-0.21, 0.4]Regression, Linear
Comparison: We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.p-value: 0.2395% CI: [-0.16, 0.68]Regression, Linear