Hypertension
Conditions
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.
Interventions
DRUGAnti-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.
DRUGAnti-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.
DRUGAnti-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.
DEVICEHome 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.
DEVICEHome 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.
DEVICEHome 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3x3 by BP agent and BP monitoring approach
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to home BP monitoring | Between month 0 and 6 | Percent of weeks with at least 9 self-measured readings per week |
Countries
United States
Outcome results
None listed