Hypertension in Young Adults Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: Anti-hypertensive agent: amlodipine; Device: Home BP monitoring with cuffed device; Drug: Anti-hypertensive agent: Chlorthalidone; Drug: Anti-hypertensive agent: Losartan; Device: Home BP monitoring with cuffed device + BP patch; Device: Home BP monitoring with cuffed device + BP watch

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elaine Ku, MD, MAS; Phone Number: 415-476-7760; Email: elaine.ku@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Elaine Ku, MD; Email: elaine.ku@ucsf.edu
      • Contact: Divya Seth; Email: divya.seth@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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.; Device: 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.
Experimental: 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	Device: 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.; 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.
Experimental: 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	Device: 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.; 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.
Experimental: 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	Drug: 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.; 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.
Experimental: 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	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.; 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.
Experimental: 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	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.; 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.
Experimental: 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	Drug: 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.; 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.
Experimental: 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	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.; 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.
Experimental: 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	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Elaine Ku, MD MAS, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Antihypertensive Agents; Losartan; Chlorthalidone
• Other Study ID Numbers: 21-35626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No