Clinical trial

Hypertension in Young Adults Trial

Name

21-35626

Description

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.

Trial arms

Trial start

2022-04-15

Estimated PCD

2025-05-01

Trial end

2027-05-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

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

Anti-hypertensive agent: Chlorthalidone

Arms:

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

Anti-hypertensive agent: Losartan

Arms:

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

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.

Arms:

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

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.

Arms:

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

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.

Arms:

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

Size

120

Primary endpoint

Achieved systolic blood pressure

Month 6

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '3x3 by BP agent and BP monitoring approach', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-08-14

1 organization

3 products

1 indication

Organization

University of California, San Francisco

Product

Indication

Product

Product