Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs)

Taipei Veterans General Hospital

Status: Unknown

Conditions: Hypertension

Treatments: Device: Home BP; Device: uAOBP; Device: CBP

Study type: Interventional

Funder types: Other

Identifiers

NCT03578848

2018-05-009A

Details and patient eligibility

About

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.

Full description

The traditional BP used for clinical practice, the office BP, is usually measured in a busy and hurry clinical environment, and interfered by the well-known confounding whitecoat effect. As such, unattended automated office BP monitoring (uAOBP) has been proposed as an effective solution and further promoted by Canadian physicians.

Nonetheless, out-of-office BP, home BP and ambulatory BP, remains the methodology of recommendation for the detection of whitecoat effect, and its prognostic value has been demonstrated to be superior to the traditional office BP. Home BP monitoring, with its ability to detect morning and masked hypertension and a better tolerability than ambulatory BP monitoring for long-term use, can therefore be considered as a strategy of choice to replace office BP monitoring for guiding hypertension management.

Moreover, BP measurements in the peripheral arteries cannot serve as direct substitutes for their central counterparts because of the long-recognized differences of blood pressure (BP) waveforms and values between the central aorta and peripheral arterial system. Thus, if the decisions on medication adjustment are made solely based brachial BP, there could be a considerable risk of over- or undertreatment.

Considering that there are many better strategies for guiding hypertension management than traditional office BP, there is an apparent need for investigating their comparative effectiveness and safety in the management of hypertension. The investigators hypothesized that home BP may be non-inferior to AOBP and central BP-guided intervention in reducing ambulatory BP and designed the present randomized controlled trial.

Enrollment: 252 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20 to 90 years of age
• nonpregnant
• receiving antihypertensive therapy for uncomplicated essential hypertension and taking ≥1 but ≤ 2 types antihypertensive drugs (to rule out complicated or resistant hypertension) or hypertension newly diagnosed by uAOBP (uAOBP >130 mmHg at screening visit)

Exclusion criteria

• Poor adherence to medication
• unable to conduct self-measurement blood pressure
• history of polycystic kidney disease
• congestive heart failure (a recent assessment of left ventricular ejection fraction < 40% prior to screening visit)
• chronic kidney disease with estimated glomerular filtration rate < 30 mL/min/1.73m2 (MDRD) at screening visit
• a recent document of severely abnormal left ventricular mass index (>59 g/m2.7 in women and >64 g/m2.7 in men) prior to screening visit
• secondary causes of hypertension
• uncontrolled hypertension (uAOBP >180/100 mm Hg at screening visit)
• history of severe aortic valve disease
• history of upper limb obstructive atherosclerosis
• history of atrial fibrillation
• BP Differences more than 5 mmHg between both arms at screening visit

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

uAOBP & Home BP

Active Comparator group

Description:

On the scheduled visits, the uAOBP and Home BP will be measured before meeting doctors and provided for clinicians to adjust patients' medication according to practice guideline.

Treatment:

Device: Home BP

Device: uAOBP

CBP & Home BP

Experimental group

Description:

On the scheduled visits, the CBP and Home BP will be measured before meeting doctors and provided for clinicians to adjust patients' medication according to practice guideline.

Treatment:

Device: Home BP

Device: CBP