Tailored Drug Titration Through Artificial Intelligence

NCT03397524 | Withdrawn DMC

• 1 other identifier: 17-21426
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Reduction in systolic BP [SBP] (mmHg) measure in the office

  optima4BP leads \>6 mmHg of the BP reduction compared to Standard of Care

  12 months

Secondary Outcomes (2)

• Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]

  12 months

• Incidence of Adverse Events

  12 months

Study Arms (2)

optima4BP

EXPERIMENTAL

optima4BP will receive several types of data to personalize the participant's medication treatment. The data include: remotely measured blood pressure (BP), and information on current medication treatment as well as health updates posted in Epic Electronic Record.

Other: optima4BP

Standard of Care

NO INTERVENTION

The participants randomized to the Standard of Care will follow usual care, as currently followed at the University of California San Francisco.

Interventions

optima4BP OTHER

optima4BP will provide the treating physician with a treatment action recommendation for consideration.

optima4BP

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Two or more blood pressure readings of ≥ 150/95 mmHg during primary care office visits in the Department of General Medicine within the last 6 months
• Therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit
• At least minimally "tech-savvy" defined as Ownership of a compatible smartphone Ability to access the internet

You may not qualify if:

• Inability to operate a blood pressure cuff
• Incompatible smartphone device (Galaxy S5 Android 5.0)
• Less than minimally "tech-savvy," defined as inability to use the Internet
• Non-compliance with medical follow-up (frequent "no shows")
• Planned coronary revascularization in the next 12 months
• Myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days
• GFR \< 30 (CKD stage IV/ V)
• Primary care provider rules out the patient due to comorbidities or other factors

Sponsors & Collaborators

• Optima Integrated Health: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94123, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gabriela Voskerician

  Optima Integrated Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient participant will be unaware of randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The interventional arm outcomes will be compared to the control.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 12, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)