Hypertension in Young Adults Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Amlodipine 2.5 mg + Home BP monitoring with cuffed device 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
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.
Device: Home BP monitoring with cuffed 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.
|
| Experimental: Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device 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
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.
Device: Home BP monitoring with cuffed 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.
|
| Experimental: Losartan 12.5 mg daily + home BP monitoring with cuffed device 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
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.
Device: Home BP monitoring with cuffed 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.
|
| Experimental: amlodipine 2.5 mg daily + home BP monitoring with patch 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
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.
Device: Home BP monitoring with cuffed device + BP patch
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.
|
| Experimental: Chlorthalidone 12.5 mg daily + home BP monitoring with patch 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
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.
Device: Home BP monitoring with cuffed device + BP patch
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.
|
| Experimental: Losartan 12.5 mg daily + home BP monitoring with patch 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
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.
Device: Home BP monitoring with cuffed device + BP patch
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.
|
| Experimental: amlodipine 2.5 mg daily + home BP monitoring with watch 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
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.
Device: Home BP monitoring with cuffed device + BP watch
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.
|
| Experimental: chlorthalidone 12.5 mg daily + home BP monitoring with watch 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
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.
Device: Home BP monitoring with cuffed device + BP watch
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.
|
| Experimental: losartan 12.5 mg daily + home BP monitoring with watch 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
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.
Device: Home BP monitoring with cuffed device + BP watch
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.
|
Outcome Measures
Primary Outcome Measures
- Achieved systolic blood pressure [Month 6]
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.
Secondary Outcome Measures
- Adherence to home BP monitoring [Between month 0 and 6]
Percent of weeks with at least 9 self-measured readings per week
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-35 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)
-
are already taking ≥3 anti-hypertensive medications (any classes, including diuretics)
-
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 < 60 mL/min/1.73 m2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Elaine Ku, MD MAS, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
- 21-35626