Hypertension in Young Adults Trial

NCT ID: NCT05370599

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2026-01-07

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Anti-hypertensive agent: amlodipine

Intervention Type: 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

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: Chlorthalidone

Intervention Type: 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

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: Losartan

Intervention Type: 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

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: amlodipine

Intervention Type: 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 + BP patch

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: Chlorthalidone

Intervention Type: 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 + BP patch

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: Losartan

Intervention Type: 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 + BP patch

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: amlodipine

Intervention Type: 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 + BP watch

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: Chlorthalidone

Intervention Type: 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 + BP watch

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Anti-hypertensive agent: Losartan

Intervention Type: 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 + BP watch

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Ku, MD MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28057065 (View on PubMed)

Other Identifiers

21-35626

Identifier Type: -

Identifier Source: org_study_id