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Using Night-time Blood Pressure to Treat Hypertension

Primary Purpose

Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

treatment of BP by using night-time BP

treatment of BP by using daytime BP

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, ABPM, nocturnal hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosed hypertension (HT) from clinical records
nocturnal HT (night-time systolic blood pressure (SBP) during sleep ≥120 mmHg) and stage I hypertension (daytime SBP = 135-159mmHg)

Exclusion Criteria:

patients with atrial fibrillation (many home blood pressure (BP) machines are not validated in these patients and these patients have greater BP variability)
daytime office systolic BP ≥180 mmHg or diastolic BP ≥120 mmHg (regardless of nocturnal BP) because these patients need urgent BP treatment and it is not known if medications given in the evening are equally effective
patients with known obstructive sleep apnoea because the night-time BP of these patients is predominately affected by the sleep apnoea
patients with known stroke, ischemic heart disease, heart failure, kidney failure, peripheral vascular disease and diabetes mellitus because their daytime BP targets will be different
dementia or psychiatric illness that impairs patients' ability to perform home blood pressure monitoring (HBPM) by themselves
patients with end-stage malignancies
nocturnal worker, because they will have a reverse BP pattern to other participants
patients who sleep after 2am or wake up before 4am because these patients will not be asleep during night HBPM
patients receiving ≥3 BP medications at maximal tolerated doses because there is little space for drug titration and these patients may have secondary HT representing another disease spectrum
patients receiving anti-coagulants because ABPM can induce significant bruises (during repeated cuff inflations) in these patients.

Sites / Locations

School of public health and primary careRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

treatment by night-time BP

treatment by daytime BP

Arm Description

titrate drug treatment in the evening against night home blood pressure monitoring (HBPM) SBP (aiming SBP of <120 mmHg; intervention group)

Usual care - titrate drug treatment in the morning against HBPM SBP (aiming SBP of <135 mmHg; control group)

Outcomes

Primary Outcome Measures

the rate of recruitment

number of participants recruited per month during recruitment period

feasibility of home blood pressure (BP) measurement

the proportion of patients who can measure nocturnal BP successfully

feasibility of repeated ambulatory blood pressure monitoring (ABPM)

the proportion of patients finished both ABPM

dropout rate

number of participants drop-out from each arm

Secondary Outcome Measures

systolic BP (SBP) / diastolic BP (DBP) on ABPM

Mean daytime/night-time/24-hour SBP/DBP

serum creatinine level

an assessment for renal function (the higher value suggest poorer renal function)

lipid profile

low-density lipoprotein (LDL), high-density lipoprotein (HDL), Triglyceride (TG), total cholesterol (TC)

microalbuminuria

the presence of microalbuminuria suggest renal damage

Full Information

NCT ID

NCT05031637

First Posted

August 29, 2021

Last Updated

August 28, 2023

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT05031637

Brief Title

Using Night-time Blood Pressure to Treat Hypertension

Official Title

Home Blood Pressure During Night-time Sleep as a Better Treatment Target for Patients With Hypertension: a Proof-of-concept Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Objectives: To examine the feasibility of conducting night-time home blood pressure(BP) monitoring (during sleep) and titration of medications in the evening. This will provide data for sample size calculation for the main trial, which will examine whether night-time BP is a better target than conventional daytime BP for hypertension management. Hypothesis to be tested: night-time home BP monitoring(HBPM) and evening drug titration are acceptable to patients; and future main trial is feasible in terms of recruitment/dropout rate/medication adherence. Design and subjects: This pilot randomized-controlled trial will recruit 78 patients with nocturnal hypertension (asleep systolic BP 120mmHg on ambulatory blood pressure monitoring(ABPM)). They will be allocated in 1:1 ratio to have their medication titrated in the evening according to night HBPM (Experimental group) or in the morning according to daytime HBPM (control group) respectively. Instruments: ABPM/HBPM. Interventions: titration of the dose(s) of anti-hypertensive medications in the evening according to night HBPM (experimental group) and in the morning according to daytime HBPM (control group) every 4 weeks. Main outcome measures: ABPM at baseline and at 6 months Data analysis and expected results: The rate of recruitment/dropout and adherence to night HBPM will be presented. The feasibility of HBPM will be assessed by the patients' adherence to HBPM and by patients' interviews. ANCOVA will be used to evaluate whether titration of medication can normalize BP levels. We expect patients to have a high adherence rate and that titration of evening doses of medications will better improve night-time BP on ABPM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

hypertension, ABPM, nocturnal hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment by night-time BP

Arm Type

Experimental

Arm Description

titrate drug treatment in the evening against night home blood pressure monitoring (HBPM) SBP (aiming SBP of <120 mmHg; intervention group)

Arm Title

treatment by daytime BP

Arm Type

Other

Arm Description

Usual care - titrate drug treatment in the morning against HBPM SBP (aiming SBP of <135 mmHg; control group)

Intervention Type

Behavioral

Intervention Name(s)

treatment of BP by using night-time BP

Intervention Description

titration of BP medications to target according to night-time SBP

Intervention Type

Behavioral

Intervention Name(s)

treatment of BP by using daytime BP

Intervention Description

titration of BP medications to target according to daytime SBP

Primary Outcome Measure Information:

Title

the rate of recruitment

Description

number of participants recruited per month during recruitment period

Time Frame

0 month to 18 month (anticipated recruitment period)

Title

feasibility of home blood pressure (BP) measurement

Description

the proportion of patients who can measure nocturnal BP successfully

Time Frame

0 month to 24 month (end of trial)

Title

feasibility of repeated ambulatory blood pressure monitoring (ABPM)

Description

the proportion of patients finished both ABPM

Time Frame

0 month to 24 month (end of trial)

Title

dropout rate

Description

number of participants drop-out from each arm

Time Frame

0 month to 24 month (end of trial)

Secondary Outcome Measure Information:

Title

systolic BP (SBP) / diastolic BP (DBP) on ABPM

Description

Mean daytime/night-time/24-hour SBP/DBP

Time Frame

taken at 0 month and 6 month for each patient

Title

serum creatinine level

Description

an assessment for renal function (the higher value suggest poorer renal function)

Time Frame

taken at 0 month and 6 month

Title

lipid profile

Description

low-density lipoprotein (LDL), high-density lipoprotein (HDL), Triglyceride (TG), total cholesterol (TC)

Time Frame

taken at 0 month and 6 month

Title

microalbuminuria

Description

the presence of microalbuminuria suggest renal damage

Time Frame

taken at 0 month and 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosed hypertension (HT) from clinical records nocturnal HT (night-time systolic blood pressure (SBP) during sleep ≥120 mmHg) and stage I hypertension (daytime SBP = 135-159mmHg) Exclusion Criteria: patients with atrial fibrillation (many home blood pressure (BP) machines are not validated in these patients and these patients have greater BP variability) daytime office systolic BP ≥180 mmHg or diastolic BP ≥120 mmHg (regardless of nocturnal BP) because these patients need urgent BP treatment and it is not known if medications given in the evening are equally effective patients with known obstructive sleep apnoea because the night-time BP of these patients is predominately affected by the sleep apnoea patients with known stroke, ischemic heart disease, heart failure, kidney failure, peripheral vascular disease and diabetes mellitus because their daytime BP targets will be different dementia or psychiatric illness that impairs patients' ability to perform home blood pressure monitoring (HBPM) by themselves patients with end-stage malignancies nocturnal worker, because they will have a reverse BP pattern to other participants patients who sleep after 2am or wake up before 4am because these patients will not be asleep during night HBPM patients receiving ≥3 BP medications at maximal tolerated doses because there is little space for drug titration and these patients may have secondary HT representing another disease spectrum patients receiving anti-coagulants because ABPM can induce significant bruises (during repeated cuff inflations) in these patients.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric Kam-Pui Lee, FRACGP, MSc

Phone

+85222528462

lkp032@cuhk.edu.hk

Facility Information:

Facility Name

School of public health and primary care

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

kam pui Lee, Msc

Phone

85260996560

lkp032@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

will share data on responsible requests

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Using Night-time Blood Pressure to Treat Hypertension

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