NCT03284099

Bedtime ACEIs/ARBs Versus Morning ACEIs/ARBs for Reverting Non-dipping Hypertension

Terminated Phase 4 Last updated 8 April 2020

What this trial tests

Phase 4 trial testing ACEi, ARB in Hypertension in 4 participants. Terminated before completion.

Timeline

1 December 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	4
Start date	1 December 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Hong Kong

Drugs / interventions tested

• ACEi, ARB

Conditions studied

• Hypertension — all drugs for Hypertension →
• Non-Dipping — all drugs for Non-Dipping →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Hypertension or Non-Dipping. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.