Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors

NCT ID: NCT04191330

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2024-08-31

Brief Summary

The goal of this real-world, multi-center, randomized, outpatient study is to assess the effectiveness of the Biofourmis cloud based BiovitalsHF platform to recommend optimal titration of Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) subjects.

Detailed Description

Patients with heart failure (HF) remain at high risk for hospitalization and death in part due to underuse of guideline directed medical therapy (GDMT). Digital interventions may facilitate rapid initiation, titration and optimization of GDMT but have not been systematically evaluated in randomized control trials. In the AIM-POWER study, we evaluated the safety and efficacy of a novel software medical application, BiovitalsHF, as a strategy to guide remote optimization of GDMT in patients with HF with reduced ejection fraction (HFrEF).

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Subjects randomized to the Intervention Arm will be remotely monitored for 90 days using the BiovitalsHF platform to manage initiation and titration of GDMT with and outside of normal or traditional clinical encounters.

Group Type: EXPERIMENTAL

BiovitalsHF

Intervention Type: DEVICE

BiovitalsHFTM is a cloud-based platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.

Interventions

BiovitalsHF

BiovitalsHFTM is a cloud-based platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects are eligible to be included in the study only if all the following criteria apply:

• Written informed consent must be obtained before any assessment is performed
• Age ≥ 22 years at signing of informed consent
• Diagnosis of heart failure with left ventricular ejection fraction ≤ 40%, EF can be assessed by any validated method, but assessment must have occurred within the last year.
• HFrEF patient not on optimal GDMT defined as:

Participant not on optimal GDMT for HFrEF per investigator judgement. This would include patients ranging from no treatments for HFrEF to a patient on multiple GDMTs for HFrEF but with at least 1 medication at 50% or less than target dose.

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply:

Therapy related

• Absolute contraindications to HF GDMT Disease related
• Heart failure hospitalization in the past 28 days.
• Baseline creatinine > 2 mg/dl or potassium level at baseline, ≥5 mEq/L or eGFR <30 mL/min/1.73 m2
• Receiving dialysis at screening
• Baseline systolic blood pressure <100 mmHg
• History of heart transplant or on transplant list
• Current or planned left ventricular assist device Comorbidity or other medical conditions
• Uncontrolled asthma
• Active wheezing on physical exam
• Uncontrolled severe COPD
• Diagnosed with cirrhosis
• Currently being treated for active malignancy and life expectancy is less than one year
• Currently receiving hospice or comfort care Prior or concurrent clinical study experience
• Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study Other General Exclusions
• Subject unable to independently navigate and operate smartphone applications
• Subject not proficient with written and spoken English or Spanish
• Subject determined likely to be non-compliant by physician/HCP
• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
• History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Biofourmis medical monitor, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
• Subject has diminished decision making capability

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biofourmis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akshay Desai, MD

Role: STUDY_CHAIR

Brigham and Womens Hospital

Adam Devore, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

Cardiology and Medicine Clinic

Little Rock, Arkansas, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Piedmont Athens Regional Medical Center

Athens, Georgia, United States

Baptist Health Louisville Heart Failure Clinic

Louisville, Kentucky, United States

Cambridge Medical Trials

Alexandria, Louisiana, United States

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

St Joseph Mercy

Ypsilanti, Michigan, United States

Jackson Heart

Jackson, Mississippi, United States

University of Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Premier Cardiovascular Institute

Dayton, Ohio, United States

Providence St Vincent Medical Center

Portland, Oregon, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Austin Heart

San Marcos, Texas, United States

Countries

United States

Other Identifiers

BV-EV-HF-1901

Identifier Type: -

Identifier Source: org_study_id