Clinical trial NCT02121041: Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
Official title: Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Blood Pressure
Ambulatory Blood Pressure Monitoring
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2014-04-23
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 24 Hour Blood Pressure Average at the End of 4 Month Participation.
timeFrame: Participants will be on study average of 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Anthony J Viera, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: