Bedtime ACEIs/ARBs Versus Morning ACEIs/ARBs for Revertin... | NCT03284099

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

NCT03284099

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Apr 8, 2020Actual

Enrollment

4Actual

Phase

Phase 4

Conditions

Hypertension
Non-Dipping

Interventions

ACEi, ARB

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding obtained. The ABPM machines are being used for another project

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Sep 13, 2017

First Submission Date that Met QC Criteria

Sep 13, 2017

First Posted Date

Sep 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2020

Last Update Posted Date

Apr 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ACEi, ARB	Drug	To take the ACEis or ARBs before bedtime instead of in the morning	control intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	The trial is deemed feasible and a larger similar study can be conducted if: (i) ≤30% of ND patients drop out from the study

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

to decide after end of trial

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000806	Angiotensin-Converting Enzyme Inhibitors

Ancestor Terms

ID	Term
D011480	Protease Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions

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Browse Branches

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