N/A
Completed N=654
Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
Blood Pressure
Source: ClinicalTrials.gov NCT04307004 ↗
Enrolled (actual)
654
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Absolute Difference Between Unattended and Attended Blood Pressure — 119.5; 72.7; 118.7; 72.2 mm Hg — p=< 0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Difference Between Unattended and Attended Blood Pressure |
119.5; 72.7; 118.7; 72.2 | < 0.0001 sig |
| PRIMARY Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor |
104.1; 60.4; 106.4; 62.3 | < 0.0001 sig |
| PRIMARY Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires |
288; 165; 410; 258; 138; 73 | — |
| SECONDARY Left Ventricular Mass Index |
67.6; 67.1; 66.9; 67.7 | < 0.001 sig |
| SECONDARY Urinary Albumin-to-creatine Ratio |
21.7; 17.0; 19.7; 18.9 | 0.17 |
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.
Data sourced from ClinicalTrials.gov (NCT04307004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.