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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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. | |
| ABPM Guided | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Amlodipine 5 mg or 10 mg |
|
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony J Viera, MD, MPH | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ABPM Guided |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 24 Hour Blood Pressure Average at the End of 4 Month Participation. | Posted | Mean | Standard Deviation | mm Hg | Participants will be on study average of 4 months. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| electrolyte | Metabolism and nutrition disorders | Systematic Assessment | Abnormal electrolyte level |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Viera | UNC Chapel Hill | 984-974-4636 | viera@med.unc.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D002752 | Chlorthalidone |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Chlorthalidone | Drug | Chlorthalidone 12.5 mg or 25 mg |
|
|
| Losartan | Drug | Losartan 50 mg or 100 mg |
|
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | 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 | 0 | 14 | 1 | 14 |
|
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| D000096926 |
| Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001713 | Biphenyl Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |