Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 8/10/2016 |
| Start Date: | May 2014 |
| End Date: | July 2016 |
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.
monitoring to usual care (blood pressure measurement in the office) in diagnosing and
managing hypertension.
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.
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.
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
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