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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amlodipine
* Drug: Chlorthalidone
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Active Comparator: ABPM Guided<br>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. | Drug: Amlodipine<br>* Amlodipine 5 mg or 10 mg<br>* Other names: Norvasc;Drug: Chlorthalidone<br>* Chlorthalidone 12.5 mg or 25 mg<br>* Other names: Thalitone;Drug: Losartan<br>* Losartan 50 mg or 100 mg<br>* Other names: Cozaar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Blood Pressure Average at the End of 4 Month Participation. |  | Participants will be on study average of 4 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Blood Pressure, Ambulatory Blood Pressure Monitoring