Technology-enabled Management Versus Usual Care for Blood Pressure (HrtEx)

Stanford University

Status: Enrolling

Conditions: Hypertension

Treatments: Other: Usual Care; Other: Digital Hypertension Management System

Study type: Interventional

Funder types: Other

Identifiers

NCT05479461

63700

Details and patient eligibility

About

Two arm parallel randomized clinical trial

Full description

Patients will be randomized 1:1 to receive mobile technology intervention versus usual care. Half of patients from a clinician team will receive the intervention and half will receive usual care. We aim to recruit at least 200 patients, 100 in each arm.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30-90 yrs.
• Smartphone ownership
• Office SBP: ≥ 140 mm Hg
• ≤ 2 current anti-HTN meds
• Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose)
• English or Spanish-speakers

Exclusion criteria

• Heart failure with reduced ejection fraction (EF < 40%)
• ESRD (GFR <15)
• Renal replacement therapy
• Pregnant
• Myocardial infarction or stroke within preceding 6 months
• Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months
• Prior solid organ transplantation
• At the clinical discretion of the investigators
• Enrolled in another clinical study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Mobile Health Technology

Experimental group

Treatment:

Other: Digital Hypertension Management System

Usual Care

Active Comparator group

Treatment:

Other: Usual Care