Hypertension Clinical Trial
Official title:
Is Bedtime Administration of ACEIs and ARBs More Effective for Reverting Non-dipper Status Than Morning Administration for Non-dipping Hypertension in Hong Kong Primary Care? A Pilot Study
Background: Non-dipping (ND), defined as a <10% decrease in blood pressure (BP) during sleep,
is an independent significant predictor of cardiovascular outcome in hypertensive patients. A
few anti-hypertensive medications, including angiotensin receptor blockers (ARBs) and
angiotensin converting enzyme inhibitors (ACEIs), may normalize dipping if administered at
night. Chinese data are scarce and there are no prospective studies on cardiovascular
outcomes in Chinese patients.
Aim: To determine if the bedtime administration of ACEIs and ARBs is more effective at
normalizing ND than morning administration. As a pilot project, the feasibility of recruiting
hypertension patients in primary care for ambulatory blood pressure monitoring (ABPM) and
conducting a clinical trial will be evaluated such that future larger randomized trials can
be planned to determine treatments for ND.
Method: Fifty patients diagnosed with essential hypertension who are receiving either ACEIs
or ARBs and diagnosed with ND will be randomized to take ACEIs or ARBs either early morning
or before bedtime. A follow-up 48-hour ABPM will be performed after 4-6 weeks to examine
post-treatment changes in BP and ND status.
Outcome: The primary outcome of this proposed study is the proportion of ND at 6 weeks;
secondary outcomes will include (i) mean awake and asleep SBP/DBP of 48-hour duration (ii)
feasibility of this pilot study will be assessed by recruitment and dropout rates during the
study period.
Potential: This pilot study will provide the basis for a future larger randomized controlled
study to further examine the treatment for ND in primary care.
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