Hypertension
Conditions
Keywords
Hypertension, Blood Pressure, Ambulatory Blood Pressure Monitoring
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.
Interventions
DRUGAmlodipine
Amlodipine 5 mg or 10 mg
DRUGChlorthalidone
Chlorthalidone 12.5 mg or 25 mg
DRUGLosartan
Losartan 50 mg or 100 mg
Sponsors
North Carolina Translational and Clinical Sciences Institute
Anthony J Viera, MD, MPH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 Hour Blood Pressure Average at the End of 4 Month Participation. | Participants will be on study average of 4 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care 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. | 14 |
| 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.
Amlodipine: Amlodipine 5 mg or 10 mg
Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg
Losartan: Losartan 50 mg or 100 mg | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Usual Care | ABPM Guided | Total |
|---|---|---|---|
| Age, Customized | 47.6 years STANDARD_DEVIATION 12 | 49.2 years STANDARD_DEVIATION 10 | 48.4 years STANDARD_DEVIATION 11 |
| Gender Female | 8 Participants | 7 Participants | 15 Participants |
| Gender Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
24 Hour Blood Pressure Average at the End of 4 Month Participation.
Time frame: Participants will be on study average of 4 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 24 Hour Blood Pressure Average at the End of 4 Month Participation. | 134 mm Hg | Standard Deviation 11 |
| ABPM Guided | 24 Hour Blood Pressure Average at the End of 4 Month Participation. | 132 mm Hg | Standard Deviation 10 |