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Completed

NCT Number: NCT05031637

Using Night-time Blood Pressure to Treat Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of public health and primary care

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treatment of BP by using night-time BP

Behavioral

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

treatment of BP by using daytime BP

Behavioral

titration of BP medications to target according to daytime SBP

Primary outcomes

  1. the rate of recruitment

    Time frame: 0 month to 18 month (anticipated recruitment period)

    number of participants recruited per month during recruitment period

  2. 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

  3. 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

  4. dropout rate

    Time frame: 0 month to 24 month (end of trial)

    number of participants drop-out from each arm

Secondary outcomes

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

    Time frame: taken at 0 month and 6 month for each patient

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

  2. serum creatinine level

    Time frame: taken at 0 month and 6 month

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

  3. lipid profile

    Time frame: taken at 0 month and 6 month

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

  4. microalbuminuria

    Time frame: taken at 0 month and 6 month

    the presence of microalbuminuria suggest renal damage

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2021
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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