Hypertension in Young Adults Trial

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 2

Conditions: Hypertension

Treatments: Drug: Anti-hypertensive agent: Losartan; Device: Home BP monitoring with cuffed device + BP watch; Drug: Anti-hypertensive agent: amlodipine; Device: Home BP monitoring with cuffed device + BP patch; Drug: Anti-hypertensive agent: Chlorthalidone; Device: Home BP monitoring with cuffed device

Study type: Interventional

Funder types: Other

Identifiers

NCT05370599

21-35626

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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36 participants in 9 patient groups

Amlodipine 2.5 mg + Home BP monitoring with cuffed device

Active Comparator group

Description:

Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring

Treatment:

Device: Home BP monitoring with cuffed device

Drug: Anti-hypertensive agent: amlodipine

Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device

Experimental group

Description:

Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring

Treatment:

Device: Home BP monitoring with cuffed device

Drug: Anti-hypertensive agent: Chlorthalidone

Losartan 12.5 mg daily + home BP monitoring with cuffed device

Experimental group

Description:

Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring

Treatment:

Device: Home BP monitoring with cuffed device

Drug: Anti-hypertensive agent: Losartan

amlodipine 2.5 mg daily + home BP monitoring with patch

Experimental group

Description:

Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring

Treatment:

Device: Home BP monitoring with cuffed device + BP patch

Drug: Anti-hypertensive agent: amlodipine

Chlorthalidone 12.5 mg daily + home BP monitoring with patch

Experimental group

Description:

Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring

Treatment:

Drug: Anti-hypertensive agent: Chlorthalidone

Device: Home BP monitoring with cuffed device + BP patch

Losartan 12.5 mg daily + home BP monitoring with patch

Experimental group

Description:

Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring

Treatment:

Device: Home BP monitoring with cuffed device + BP patch

Drug: Anti-hypertensive agent: Losartan

amlodipine 2.5 mg daily + home BP monitoring with watch

Experimental group

Description:

Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring

Treatment:

Drug: Anti-hypertensive agent: amlodipine

Device: Home BP monitoring with cuffed device + BP watch

chlorthalidone 12.5 mg daily + home BP monitoring with watch

Experimental group

Description:

Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring

Treatment:

Drug: Anti-hypertensive agent: Chlorthalidone

Device: Home BP monitoring with cuffed device + BP watch

losartan 12.5 mg daily + home BP monitoring with watch

Experimental group

Description:

Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring

Treatment:

Device: Home BP monitoring with cuffed device + BP watch

Drug: Anti-hypertensive agent: Losartan