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Using Night-time Blood Pressure to Treat Hypertension

NCT05031637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-05-02

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

treatment of BP by using night-time BP

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

BEHAVIORAL

treatment of BP by using daytime BP

titration of BP medications to target according to daytime SBP

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-01-31
Completion
2024-02-28

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05031637 on ClinicalTrials.gov