Hypertension in Young Adults Trial

Phase 2

Active, not recruiting

• Conditions: Hypertension
• Interventions: Device: Home BP monitoring with cuffed device; Device: Home BP monitoring with cuffed device + BP watch; Device: Home BP monitoring with cuffed device + BP patch

• Registration Number: NCT05370599
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-15
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device	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
amlodipine 2.5 mg daily + home BP monitoring with watch	Home BP monitoring with cuffed device + BP 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
Amlodipine 2.5 mg + Home BP monitoring with cuffed device	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
Losartan 12.5 mg daily + home BP monitoring with cuffed device	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
amlodipine 2.5 mg daily + home BP monitoring with patch	Home BP monitoring with cuffed device + BP 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
Losartan 12.5 mg daily + home BP monitoring with patch	Home BP monitoring with cuffed device + BP 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
losartan 12.5 mg daily + home BP monitoring with watch	Home BP monitoring with cuffed device + BP 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
Chlorthalidone 12.5 mg daily + home BP monitoring with patch	Home BP monitoring with cuffed device + BP 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
chlorthalidone 12.5 mg daily + home BP monitoring with watch	Home BP monitoring with cuffed device + BP 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adherence to home BP monitoring	Between month 0 and 6	Percent of weeks with at least 9 self-measured readings per week

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States