Recruiting

Technology-enabled Management

Sponsor:

Stanford University

Code:

NCT05479461

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Digital Hypertension Management System

Usual Care

Study Details

Brief summary:

Two arm parallel randomized clinical trial

Conditions

Hypertension

Study ID

NCT05479461

Start date

Jun 13, 2023

Status verified date

Aug, 2025

Completion date

Sep 15, 2025

Anticipated

Primary completion date

Sep 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mobile Health Technology

active comparator: Usual Care

Interventions

Digital Hypertension Management System

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

Usual Care

The participants will receive usual care

Primary outcome measure

  • Defined Daily Dose (DDD) [ Time Frame: Visit 1 (Baseline), Visit-3 (6 Month follow up) ]

Central Contacts and Locations

Central contacts

Paul J Wang, MD

(650) 723-9363pjwang@stanford.edu

Meg Babakhanian, PhD

818-618-4764mbabakha@stanford.edu

Locations

Stanford Health Care

Recruiting

Palo Alto, California, United States, 94305

Contacts

Paul Wang, MD

650-723-9363pjwang@stanford.edu

Meg Babakhanian, PhD

818-618-4764mbabakha@stanford.edu

Principal Investigator:

Paul Wang, MD

Morehouse School of Medicine

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Wendi Wright, MD

470-681-4239wewright@msm.edu

Principal Investigator:

Melvin Echols, MD

Lake Country Medical Group

Recruiting

Eatonton, Georgia, United States, 31024

Contacts

Nicolas Chronos, MD

706-485-4004drchronos@cardiologycareclinics.com

Asher Miller, BS

404-731-5467asher.miller@cardiologycareclinics.com

Principal Investigator:

Nicolas Chronos, MD

More Information

Sponsor

Stanford University

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-08-11.