An interventional study of treatment of BP by using night-time BP and treatment of BP by using daytime BP in Hypertension, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 78 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
titrate drug treatment in the evening against night home blood pressure monitoring (HBPM) SBP (aiming SBP of \<120 mmHg; intervention group)
Behavioral: treatment of BP by using night-time BP
Usual care - titrate drug treatment in the morning against HBPM SBP (aiming SBP of \<135 mmHg; control group)
Behavioral: treatment of BP by using daytime BP
titration of BP medications to target according to night-time SBP
titration of BP medications to target according to daytime SBP
the rate of recruitment
number of participants recruited per month during recruitment period
Time frame: 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
Time frame: 0 month to 24 month (end of trial)
feasibility of repeated ambulatory blood pressure monitoring (ABPM)
the proportion of patients finished both ABPM
Time frame: 0 month to 24 month (end of trial)
dropout rate
number of participants drop-out from each arm
Time frame: 0 month to 24 month (end of trial)
systolic BP (SBP) / diastolic BP (DBP) on ABPM
Mean daytime/night-time/24-hour SBP/DBP
Time frame: 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)
Time frame: taken at 0 month and 6 month
lipid profile
low-density lipoprotein (LDL), high-density lipoprotein (HDL), Triglyceride (TG), total cholesterol (TC)
Time frame: taken at 0 month and 6 month
microalbuminuria
the presence of microalbuminuria suggest renal damage
Time frame: taken at 0 month and 6 month
Plan to share: Undecided — will share data on responsible requests
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →