Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies

Summary

Patients with uncontrolled or newly diagnosed hypertension will be randomized to have hypertension management decisions made on the basis of the unattended automated blood pressure (uAOBP) , home BP, and central BP monitoring. This study evaluates the optimal guiding strategy for hypertension will help define which BP monitoring is the most effective strategy to guide the clinical management of hypertension.

Conditions

• Hypertension

Interventions

DEVICE

uAOBP

For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.

DEVICE

Home BP

As for the home BP measurements, a validated device (WatchBP Home; Microlife AG, Widnau, Switzerland) will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning (within 2 hours after awakening) and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP (all BP reading and BP in the morning and in the afternoon) will be generated and provided for clinicians to guide their treatment.

DEVICE

CBP

For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan

  lead OTHER_GOV

Principal Investigators

• Hao-Min Cheng, M.D., Ph.D. · Taipei Veterans General Hospital, Taipei, Taiwan

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-06

Primary Completion

2019-06-01

Completion

2020-03-01

Countries

• Taiwan

Study Locations