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

NCT ID: NCT03284099

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-12-31

Brief Summary

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.

Conditions

Hypertension; Non-Dipping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention

ACEIs or ARBs will be switch to be taken before bedtime

Group Type: EXPERIMENTAL

ACEi, ARB

Intervention Type: DRUG

To take the ACEis or ARBs before bedtime instead of in the morning

control

ACEIs or ARBs will be taken in the morning as usual

Group Type: ACTIVE_COMPARATOR

ACEi, ARB

Intervention Type: DRUG

To take the ACEis or ARBs before bedtime instead of in the morning

Interventions

ACEi, ARB

To take the ACEis or ARBs before bedtime instead of in the morning

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who are taking an ACEI or an ARB
• >18 years of age
• Chinese and
• Received a diagnosis of primary HT.

Exclusion Criteria

• Severe HT as defined by a clinic systolic BP ≥180 mmHg and/or diastolic BP ≥ 110 mmHg
• allergic reaction or intolerance to the current ACEI or ARB
• unable to provide consent
• pregnancy
• night-time worker
• occupational drivers since patients will be asked not to move during BP measurements, which may induce potential danger in driving
• taking anti-coagulants to avoid causing bruises when using ABPM
• known atrial fibrillation since ABPM use has not been validated in this group
• known hyperkalemia
• ABPM discovered hypotension (mean SBP < 100 and/or mean DBP < 60) because these patients may need to stop their medications
• Reported sleep time of <4 hours per night (at least seven readings are recommended during sleep for an ABPM recording to be valid, and a sleeping time < 4 hours is unlikely to generate valid results).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lee Kam Pui

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lek Yuen Clinic

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2017.182-T

Identifier Type: -

Identifier Source: org_study_id