Tailored Drug Titration Through Artificial Intelligence

Hypertension Clinical Trial

— ARTERY  

Official title:

Tailored Drug Titration Through Artificial Intelligence: an Interventional Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03397524
• Other study ID #: 17-21426
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: September 2019
• Source: Optima Integrated Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. Chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the United States. Poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. The platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. The results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. The principal investigator has just completed a pilot study in conjunction with Optima Inrwgrated Health, Inc. (i.e. PRECISION) to successfully test the medication management platform technology and its integration with the electronic medical record (EPIC® platform).

Optima-for-Blood Pressure (O4BP) is a cloud-based artificial intelligence clinical decision support system (CDSS) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. O4BP provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. The goal of the study is to test if blood pressure management by using the O4BP CDSS is superior to standard of care (SOC) (i.e. blood pressure management during office visits).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Optima Integrated Health	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]	optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care baseline through 12 months of enrollment.	12 months
Secondary	Incidence of Adverse Events	Frequency and severity of adverse events (AEs) between baseline and the end of the study.	12 months