Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Amlodipine
- Conditions
- Hypertension
- Sponsor
- Anthony J Viera, MD, MPH
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- 24 Hour Blood Pressure Average at the End of 4 Month Participation.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Anthony J Viera, MD, MPH
Distinguished Associate Professor, Family Medicine
University of North Carolina, Chapel Hill
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
Arms & Interventions
ABPM Guided
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.
Intervention: Amlodipine
ABPM Guided
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.
Intervention: Chlorthalidone
ABPM Guided
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.
Intervention: Losartan
Outcomes
Primary Outcomes
24 Hour Blood Pressure Average at the End of 4 Month Participation.
Time Frame: Participants will be on study average of 4 months.