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Funding limitations.
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This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine 2.5 mg + Home BP monitoring with cuffed device | Active Comparator | Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring |
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| Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device | Experimental | Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring |
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| Losartan 12.5 mg daily + home BP monitoring with cuffed device | Experimental | Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring |
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| amlodipine 2.5 mg daily + home BP monitoring with patch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring |
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| Chlorthalidone 12.5 mg daily + home BP monitoring with patch |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-hypertensive agent: amlodipine | Drug | Patients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets. |
| Measure | Description | Time Frame |
|---|---|---|
| Achieved systolic blood pressure | Systolic blood pressure will be collected using at home cuffed devices. The readings at end of the pilot trial (or most recent readings available) will be used for analysis of the primary outcome. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to home BP monitoring | Percent of weeks with at least 9 self-measured readings per week | Between month 0 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Ku, MD MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28057065 | Background | Johnson HM, Warner RC, Bartels CM, LaMantia JN. "They're younger... it's harder." Primary providers' perspectives on hypertension management in young adults: a multicenter qualitative study. BMC Res Notes. 2017 Jan 3;10(1):9. doi: 10.1186/s13104-016-2332-8. |
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3x3 by BP agent and BP monitoring approach
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| Experimental |
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring |
|
| Losartan 12.5 mg daily + home BP monitoring with patch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring |
|
| amlodipine 2.5 mg daily + home BP monitoring with watch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring |
|
| chlorthalidone 12.5 mg daily + home BP monitoring with watch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring |
|
| losartan 12.5 mg daily + home BP monitoring with watch | Experimental | Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring |
|
| Anti-hypertensive agent: Chlorthalidone | Drug | Patients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets. |
|
| Anti-hypertensive agent: Losartan | Drug | Patients with hypertension will be randomly assigned to be treated with amlodipine, chlorthalidone, or losartan. All drugs will be initiated at the lowest dose and uptitrated as needed to achieve standard BP targets. |
|
| Home BP monitoring with cuffed device | Device | Patients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch. |
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| Home BP monitoring with cuffed device + BP patch | Device | Patients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch. |
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| Home BP monitoring with cuffed device + BP watch | Device | Patients will be randomized to monitor their blood pressure either with a BP cuffed device alone, versus with either or use of a BP monitoring patch or BP monitoring watch. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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