Hypertension in Young Adults Trial

Hypertension Clinical Trial

Official title:

Hypertension in Young Adults Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370599
• Other study ID #: 21-35626
• Status: Recruiting
• Phase: Phase 2
• Start date: April 15, 2022
• Est. completion date: May 1, 2027

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Elaine Ku, MD, MAS
• Phone: 415-476-7760
• Email: elaine.ku[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.
• 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
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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to home BP monitoring	Percent of weeks with at least 9 self-measured readings per week	Between month 0 and 6