Hypertension in Young Adults Trial

NCT05370599 | Terminated Phase 2 FDA Drug FDA Device

• 1 other identifier: 21-35626
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adherence to home BP monitoring

  Between month 0 and 6

Study Arms (9)

Amlodipine 2.5 mg + Home BP monitoring with cuffed device

ACTIVE COMPARATOR

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; Device: Home BP monitoring with cuffed device

Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device

Losartan 12.5 mg daily + home BP monitoring with cuffed device

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device

amlodipine 2.5 mg daily + home BP monitoring with patch

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device + BP patch

Chlorthalidone 12.5 mg daily + home BP monitoring with patch

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device + BP patch

Losartan 12.5 mg daily + home BP monitoring with patch

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device + BP patch

amlodipine 2.5 mg daily + home BP monitoring with watch

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device + BP watch

chlorthalidone 12.5 mg daily + home BP monitoring with watch

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device + BP watch

losartan 12.5 mg daily + home BP monitoring with watch

EXPERIMENTAL

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; Device: Home BP monitoring with cuffed device + BP watch

Interventions

Anti-hypertensive agent: Losartan 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.

Losartan 12.5 mg daily + home BP monitoring with cuffed device; Losartan 12.5 mg daily + home BP monitoring with patch; losartan 12.5 mg daily + home BP monitoring with watch

Anti-hypertensive agent: Chlorthalidone 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.

Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device; Chlorthalidone 12.5 mg daily + home BP monitoring with patch; chlorthalidone 12.5 mg daily + home BP monitoring with watch

Home BP monitoring with cuffed device 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 + Home BP monitoring with cuffed device; Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device; Losartan 12.5 mg daily + home BP monitoring with cuffed device

Home BP monitoring with cuffed device + BP patch 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; Losartan 12.5 mg daily + home BP monitoring with patch; amlodipine 2.5 mg daily + home BP monitoring with patch

Home BP monitoring with cuffed device + BP watch 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; chlorthalidone 12.5 mg daily + home BP monitoring with watch; losartan 12.5 mg daily + home BP monitoring with watch

Anti-hypertensive agent: amlodipine 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.

Amlodipine 2.5 mg + Home BP monitoring with cuffed device; amlodipine 2.5 mg daily + home BP monitoring with patch; amlodipine 2.5 mg daily + home BP monitoring with watch

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 28057065 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elaine Ku, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3x3 by BP agent and BP monitoring approach

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: April 15, 2022
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)