HypertensionNCT05031637
Using Night-time Blood Pressure to Treat Hypertension
A study testing treatment of BP by using night-time BP and treatment of BP by using daytime BP in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- treatment of BP by using night-time BP and treatment of BP by using daytime BP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Hypertension
- Being tested
- treatment of BP by using night-time BP, treatment of BP by using daytime BP
- Keywords
- hypertension, ABPM, nocturnal hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of BP by using night-time BPBehavioural
titration of BP medications to target according to night-time SBP
treatment of BP by using daytime BPBehavioural
titration of BP medications to target according to daytime SBP
| Study group | Role | What they receive |
|---|---|---|
| treatment by night-time BP | Experimental | titrate drug treatment in the evening against night home blood pressure monitoring (HBPM) SBP (aiming SBP of <120 mmHg; intervention group) Receives: Behavioral: treatment of BP by using night-time BP |
| treatment by daytime BP | Other | Usual care - titrate drug treatment in the morning against HBPM SBP (aiming SBP of <135 mmHg; control group) Receives: Behavioral: treatment of BP by using daytime BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of recruitment
number of participants recruited per month during recruitment period
Measured: 0 month to 18 month (anticipated recruitment period)
feasibility of home blood pressure (BP) measurement
the proportion of patients who can measure nocturnal BP successfully
Measured: 0 month to 24 month (end of trial)
feasibility of repeated ambulatory blood pressure monitoring (ABPM)
the proportion of patients finished both ABPM
Measured: 0 month to 24 month (end of trial)
dropout rate
number of participants drop-out from each arm
Measured: 0 month to 24 month (end of trial)
Secondary outcomes (4)
systolic BP (SBP) / diastolic BP (DBP) on ABPM
Mean daytime/night-time/24-hour SBP/DBP
Measured: taken at 0 month and 6 month for each patient
serum creatinine level
an assessment for renal function (the higher value suggest poorer renal function)
Measured: taken at 0 month and 6 month
lipid profile
low-density lipoprotein (LDL), high-density lipoprotein (HDL), Triglyceride (TG), total cholesterol (TC)
Measured: taken at 0 month and 6 month
microalbuminuria
the presence of microalbuminuria suggest renal damage
Measured: taken at 0 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 May 2022
- Primary completion31 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031637
- Sponsor's protocol ID
- 2021.253-T
- Status last verified
- Apr 2024
- First submitted
- 29 Aug 2021
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will share data on responsible requests
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05031637
- Acronym / sponsor ID
- 2021.253-T
- Conditions
- Hypertension
- Keywords
- hypertension, ABPM, nocturnal hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment by night-time BP | Experimental | Behavioral: treatment of BP by using night-time BPtitrate drug treatment in the evening against night home blood pressure monitoring (HBPM) SBP (aiming SBP of <120 mmHg; intervention group) |
| treatment by daytime BP | Other | Behavioral: treatment of BP by using daytime BPUsual care - titrate drug treatment in the morning against HBPM SBP (aiming SBP of <135 mmHg; control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment of BP by using night-time BPtitration of BP medications to target according to night-time SBP | Behavioural | treatment by night-time BP |
| treatment of BP by using daytime BPtitration of BP medications to target according to daytime SBP | Behavioural | treatment by daytime BP |
Primary outcome
the rate of recruitment
Time frame: 0 month to 18 month (anticipated recruitment period)
number of participants recruited per month during recruitment period
feasibility of home blood pressure (BP) measurement
Time frame: 0 month to 24 month (end of trial)
the proportion of patients who can measure nocturnal BP successfully
feasibility of repeated ambulatory blood pressure monitoring (ABPM)
Time frame: 0 month to 24 month (end of trial)
the proportion of patients finished both ABPM
dropout rate
Time frame: 0 month to 24 month (end of trial)
number of participants drop-out from each arm
4 secondary outcomes
systolic BP (SBP) / diastolic BP (DBP) on ABPM
Time frame: taken at 0 month and 6 month for each patient
serum creatinine level
Time frame: taken at 0 month and 6 month
lipid profile
Time frame: taken at 0 month and 6 month
microalbuminuria
Time frame: taken at 0 month and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Undecided. will share data on responsible requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment of BP by using night-time BP and treatment of BP by using daytime BP in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of recruitment (time frame: 0 month to 18 month (anticipated recruitment period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.