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

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Stanford University

Status

Enrolling

Conditions

Hypertension

Treatments

Other: Usual Care
Other: Digital Hypertension Management System

Study type

Interventional

Funder types

Other

Identifiers

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)

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

Trial contacts and locations

1

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Central trial contact

Paul J Wang, MD; Karma Lhamo, MSc

Data sourced from clinicaltrials.gov

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