Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Anthony J Viera, MD, MPH

Status: Completed

Conditions: Hypertension

Treatments: Drug: Amlodipine; Drug: Losartan; Drug: Chlorthalidone

Study type: Interventional

Funder types: Other

Identifiers

NCT02121041

14-0670

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.

Full description

The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.

Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.

Enrollment: 28 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 30 years and ≤ 65 years
• Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
• Able/willing to wear a BP monitor for 24 hours on multiple occasions
• Able/willing to take daily anti-hypertensive medication if indicated
• Able to read and speak English

Exclusion criteria

• Pregnant or trying to become pregnant
• Known heart disease
• History of persistent atrial fibrillation
• Currently taking antihypertensive medication
• Currently taking Simvastatin > 20mg daily
• Clinician recommends against participation

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.

ABPM Guided

Active Comparator group

Description:

Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.

Treatment:

Drug: Chlorthalidone

Drug: Losartan

Drug: Amlodipine