Technology-enabled Management Versus Usual Care for Blood Pressure

NCT05479461 | Recruiting DMC

• 1 other identifier: 63700
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Two arm parallel randomized clinical trial

Conditions

Hypertension

Keywords

High blood pressure; Digital Health Mobile Technology; Cardiovascular risk; Clinical Research; Medications

Outcome Measures

Primary Outcomes (1)

• Defined Daily Dose (DDD)

  Change in defined daily dose (DDD)

  Visit 1 (Baseline), Visit-3 (6 Month follow up)

Secondary Outcomes (6)

• Systolic Blood Pressure (SBP)

  Visit-1 (Baseline), Visit-3 (6 Month follow up)

• Diastolic blood pressure (DBP)

  Visit-1 (Baseline), Visit-3 (6 Month follow up)

• Antihypertensive Drugs

  Visit-1 (Baseline), Visit-3 (6 Month follow up)

• Systolic Blood Pressure (SBP)

  Visit-1 (Baseline), Visit -2 (3 Month follow up)

• Physician Survey

  Visit 1 (Baseline), Visit-3 (6 Month follow up)

Study Arms (2)

Mobile Health Technology

EXPERIMENTAL

Other: Digital Hypertension Management System

Usual Care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Digital Hypertension Management System OTHER

Mobile health technology using physician- directed, semi-automated management of hypertension

Mobile Health Technology

Usual Care OTHER

The participants will receive usual care

Usual Care

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Stanford Health Care

Palo Alto, California, 94305, United States

RECRUITING

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

Lake Country Medical Group

Eatonton, Georgia, 31024, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul J Wang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul J Wang, MD

CONTACT

(650) 723-9363; pjwang@stanford.edu

Meg Babakhanian, PhD

CONTACT

818-618-4764; mbabakha@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiovascular Medicine), Stanford University Medical Center

Model Details: Randomized open label

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 29, 2022
• Study Start: June 13, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)