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

NCT03284099 | Terminated Phase 4

• 1 other identifier: 2017.182-T
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• proportion of non-dipping in each group as measured by ambulatory BP machines(ABPM)

  the ABPM - An ApneABP (Meditech, Hungary) will be used in the study. non-dipping is defined as lack of more than 10% drop in SBP during sleep when compared to awake BP. The sleep duration and time are defined by actigraphy (Actigraph, model GT9X-BT)

  6 weeks

Secondary Outcomes (2)

• mean awake and asleep SBP/DBP of 48-hour duration as assessed by ABPM

  6 weeks

• feasibility of the intervention as assessed by dropout rate

  1 year (assessed after the whole study)

Study Arms (2)

intervention

EXPERIMENTAL

ACEIs or ARBs will be switch to be taken before bedtime

Drug: ACEi, ARB

control

ACTIVE COMPARATOR

ACEIs or ARBs will be taken in the morning as usual

Drug: ACEi, ARB

Interventions

ACEi, ARB DRUG

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

control; intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Lek Yuen Clinic

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension

Interventions

Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

HK (1)