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Objectives: To examine the feasibility of conducting night-time home blood pressure(BP) monitoring (during sleep) and titration of medications in the evening. This will provide data for sample size calculation for the main trial, which will examine whether night-time BP is a better target than conventional daytime BP for hypertension management.
Hypothesis to be tested: night-time home BP monitoring(HBPM) and evening drug titration are acceptable to patients; and future main trial is feasible in terms of recruitment/dropout rate/medication adherence.
Design and subjects: This pilot randomized-controlled trial will recruit 78 patients with nocturnal hypertension (asleep systolic BP 120mmHg on ambulatory blood pressure monitoring(ABPM)). They will be allocated in 1:1 ratio to have their medication titrated in the evening according to night HBPM (Experimental group) or in the morning according to daytime HBPM (control group) respectively.
Instruments: ABPM/HBPM. Interventions: titration of the dose(s) of anti-hypertensive medications in the evening according to night HBPM (experimental group) and in the morning according to daytime HBPM (control group) every 4 weeks.
Main outcome measures: ABPM at baseline and at 6 months Data analysis and expected results: The rate of recruitment/dropout and adherence to night HBPM will be presented. The feasibility of HBPM will be assessed by the patients' adherence to HBPM and by patients' interviews. ANCOVA will be used to evaluate whether titration of medication can normalize BP levels. We expect patients to have a high adherence rate and that titration of evening doses of medications will better improve night-time BP on ABPM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment by night-time BP | Experimental | titrate drug treatment in the evening against night home blood pressure monitoring (HBPM) SBP (aiming SBP of <120 mmHg; intervention group) |
|
| treatment by daytime BP | Other | Usual care - titrate drug treatment in the morning against HBPM SBP (aiming SBP of <135 mmHg; control group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment of BP by using night-time BP | Behavioral | titration of BP medications to target according to night-time SBP |
|
| Measure | Description | Time Frame |
|---|---|---|
| the rate of recruitment | number of participants recruited per month during recruitment period | 0 month to 18 month (anticipated recruitment period) |
| feasibility of home blood pressure (BP) measurement | the proportion of patients who can measure nocturnal BP successfully | 0 month to 24 month (end of trial) |
| feasibility of repeated ambulatory blood pressure monitoring (ABPM) | the proportion of patients finished both ABPM | 0 month to 24 month (end of trial) |
| dropout rate | number of participants drop-out from each arm | 0 month to 24 month (end of trial) |
| Measure | Description | Time Frame |
|---|---|---|
| systolic BP (SBP) / diastolic BP (DBP) on ABPM | Mean daytime/night-time/24-hour SBP/DBP | taken at 0 month and 6 month for each patient |
| serum creatinine level | an assessment for renal function (the higher value suggest poorer renal function) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of public health and primary care | Hong Kong | Hong Kong |
will share data on responsible requests
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| treatment of BP by using daytime BP | Behavioral | titration of BP medications to target according to daytime SBP |
|
| taken at 0 month and 6 month |
| lipid profile | low-density lipoprotein (LDL), high-density lipoprotein (HDL), Triglyceride (TG), total cholesterol (TC) | taken at 0 month and 6 month |
| microalbuminuria | the presence of microalbuminuria suggest renal damage | taken at 0 month and 6 month |