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

NCT04191330 | Active Not Recruiting FDA Device

• 1 other identifier: BV-EV-HF-1901
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 14

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• • To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTx to improve guideline-directed medical therapy (GDMT) adoption in subjects with heart failure with reduced ejection fraction (HFrEF) after 90 days of using the platform

  The primary endpoint will be the between-group difference in the change at 90 days, between the intervention and control arm in heart failure optimal therapy score. Heart Failure Optimal Therapy Score: A heart failure optimal therapy score was developed (see Table S9 below) based on clinical practice guidelines, including the 2021 Update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment {REF}. One point is awarded for initiating evidence-based BB, MRA, or ARNI and two points for up titrating those classes of medications to 50% or higher target dose. Two points are awarded for initiating SGLT2 inhibitor as there is a single approved dose (and no opportunity for dose titration). Finally, if a patient is not on an ARNI, one point is awarded for ACEi/ARB at 50% or higher target dose. Of note, ARNI patients do not receive points for ACEi/ARB. The maximum possible score is 8 points, and the minimum possible score is 0 points.

  90 days

Secondary Outcomes (7)

• • To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTX to improve the composite clinical outcome by calculating the win ratio between treatment and control arm.

  90 days

• • To assess the effectiveness of the Biofourmis cloud based BiovitalsHF DTx to help improve GDMT adoption and on clinical outcomes.

  90 days

• GDMT initiation

  90 days

• Quadruple therapy

  90 days

• Time to GDMT optimization

  90 days

Other Outcomes (1)

• Change in quality of life and function

  90 days

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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.

Device: BiovitalsHF

Interventions

BiovitalsHF 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.

Intervention

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biofourmis Inc.: lead

Study Sites (14)

Cardiology and Medicine Clinic

Little Rock, Arkansas, 72204, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30306, United States

Location

Baptist Health Louisville Heart Failure Clinic

Louisville, Kentucky, 40207, United States

Location

Cambridge Medical Trials

Alexandria, Louisiana, 71301, United States

Location

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

St Joseph Mercy

Ypsilanti, Michigan, 48197, United States

Location

Jackson Heart

Jackson, Mississippi, 39216, United States

Location

University of Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Premier Cardiovascular Institute

Dayton, Ohio, 45414, United States

Location

Providence St Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Austin Heart

San Marcos, Texas, 78666, United States

Location

Related Publications (1)

• DeVore AD, Majmudar M, Etters L, Xie J, Hao C, Lam PH, Hernandez AF, Fonarow GC, Desai AS. Digital Platform to Optimize Guideline-Directed Heart Failure Therapy: Results of the AIM-POWER Trial. Circ Heart Fail. 2025 Dec 3:e013231. doi: 10.1161/CIRCHEARTFAILURE.125.013231. Online ahead of print.

  PMID: 41332416 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Akshay Desai, MD

  Brigham and Womens Hospital

  STUDY CHAIR

• Adam Devore, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: January 27, 2020
• Primary Completion: June 14, 2024
• Study Completion: August 31, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)