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Hypertension in Young Adults Trial

Primary Purpose

Hypertension

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anti-hypertensive agent: amlodipine
Anti-hypertensive agent: Chlorthalidone
Anti-hypertensive agent: Losartan
Home BP monitoring with cuffed device
Home BP monitoring with cuffed device + BP patch
Home BP monitoring with cuffed device + BP watch
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-35 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)
  • are already taking ≥3 anti-hypertensive medications (any classes, including diuretics)
  • 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 < 60 mL/min/1.73 m2

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

amlodipine 2.5 mg daily + home BP monitoring with patch

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 watch

chlorthalidone 12.5 mg daily + home BP monitoring with watch

losartan 12.5 mg daily + home BP monitoring with watch

Arm Description

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adherence to home BP monitoring
Percent of weeks with at least 9 self-measured readings per week

Full Information

First Posted
May 6, 2022
Last Updated
August 10, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05370599
Brief Title
Hypertension in Young Adults Trial
Official Title
Hypertension in Young Adults Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
3x3 by BP agent and BP monitoring approach
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amlodipine 2.5 mg + Home BP monitoring with cuffed device
Arm Type
Active Comparator
Arm Description
Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring
Arm Title
Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device
Arm Type
Experimental
Arm Description
Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring
Arm Title
Losartan 12.5 mg daily + home BP monitoring with cuffed device
Arm Type
Experimental
Arm Description
Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring
Arm Title
amlodipine 2.5 mg daily + home BP monitoring with patch
Arm Type
Experimental
Arm 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
Arm Title
Chlorthalidone 12.5 mg daily + home BP monitoring with patch
Arm Type
Experimental
Arm 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
Arm Title
Losartan 12.5 mg daily + home BP monitoring with patch
Arm Type
Experimental
Arm 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
Arm Title
amlodipine 2.5 mg daily + home BP monitoring with watch
Arm Type
Experimental
Arm 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
Arm Title
chlorthalidone 12.5 mg daily + home BP monitoring with watch
Arm Type
Experimental
Arm 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
Arm Title
losartan 12.5 mg daily + home BP monitoring with watch
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Anti-hypertensive agent: amlodipine
Intervention Description
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
Intervention Name(s)
Anti-hypertensive agent: Chlorthalidone
Intervention Description
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
Intervention Name(s)
Anti-hypertensive agent: Losartan
Intervention Description
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
Device
Intervention Name(s)
Home BP monitoring with cuffed device
Intervention Description
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
Intervention Name(s)
Home BP monitoring with cuffed device + BP patch
Intervention Description
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
Intervention Name(s)
Home BP monitoring with cuffed device + BP watch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Achieved systolic blood pressure
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Adherence to home BP monitoring
Description
Percent of weeks with at least 9 self-measured readings per week
Time Frame
Between month 0 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Ku, MD, MAS
Phone
415-476-7760
Email
elaine.ku@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Ku, MD MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Ku, MD
Email
elaine.ku@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Divya Seth
Email
divya.seth@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28057065
Citation
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.
Results Reference
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Hypertension in Young Adults Trial

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