Hypertension in Young Adults Trial

Study Overview
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Brief Summary
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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.

Official Title
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Hypertension in Young Adults Trial

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Anti-hypertensive agent: amlodipine
* Drug: Anti-hypertensive agent: Chlorthalidone
* Drug: Anti-hypertensive agent: Losartan
* Device: Home BP monitoring with cuffed device
* Device: Home BP monitoring with cuffed device + BP patch
* Device: Home BP monitoring with cuffed device + BP watch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-40 years of age Diagnosis of hypertension or receiving anti-hypertensive therapy OR Has clinical BP readings >130/80 mmHg that would meet the definition of hypertension and have home BP readings >=125/80 mmHg Exclusion Criteria: are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents are marginally housed, due to concerns regarding routine follow-up are actively participating in a different interventional trial that may affect blood pressure are unwilling to consent to participate institutionalized individuals or prisoners are actively abusing illicit drugs or alcohol have a history of poor or doubtful compliance (e.g., frequently missed appointments) have cognitive impairment prohibiting participation in the study History of allergy to any of the randomized medications Serum potassium >5.5 meq/L at the screening visit BP > 160/100 mmHg in clinic (stage II hypertension), regardless of whether patient is on therapy eGFR < 30 mL/min/1.73 m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 3x3 by BP agent and BP monitoring approach
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amlodipine 2.5 mg + Home BP monitoring with cuffed device<br>Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring | Drug: Anti-hypertensive agent: amlodipine<br>* 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.<br>Device: Home BP monitoring with cuffed device<br>* 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.<br>|
| Experimental: Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device<br>Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring | Drug: Anti-hypertensive agent: Chlorthalidone<br>* 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.<br>Device: Home BP monitoring with cuffed device<br>* 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.<br>|
| Experimental: Losartan 12.5 mg daily + home BP monitoring with cuffed device<br>Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring | Drug: Anti-hypertensive agent: Losartan<br>* 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.<br>Device: Home BP monitoring with cuffed device<br>* 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.<br>|
| Experimental: amlodipine 2.5 mg daily + home BP monitoring with patch<br>Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring | Drug: Anti-hypertensive agent: amlodipine<br>* 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.<br>Device: Home BP monitoring with cuffed device + BP patch<br>* 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.<br>|
| Experimental: Chlorthalidone 12.5 mg daily + home BP monitoring with patch<br>Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring | Drug: Anti-hypertensive agent: Chlorthalidone<br>* 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.<br>Device: Home BP monitoring with cuffed device + BP patch<br>* 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.<br>|
| Experimental: Losartan 12.5 mg daily + home BP monitoring with patch<br>Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring | Drug: Anti-hypertensive agent: Losartan<br>* 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.<br>Device: Home BP monitoring with cuffed device + BP patch<br>* 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.<br>|
| Experimental: amlodipine 2.5 mg daily + home BP monitoring with watch<br>Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring | Drug: Anti-hypertensive agent: amlodipine<br>* 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.<br>Device: Home BP monitoring with cuffed device + BP watch<br>* 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.<br>|
| Experimental: chlorthalidone 12.5 mg daily + home BP monitoring with watch<br>Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring | Drug: Anti-hypertensive agent: Chlorthalidone<br>* 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.<br>Device: Home BP monitoring with cuffed device + BP watch<br>* 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.<br>|
| Experimental: losartan 12.5 mg daily + home BP monitoring with watch<br>Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring | Drug: Anti-hypertensive agent: Losartan<br>* 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.<br>Device: Home BP monitoring with cuffed device + BP watch<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |