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

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

Detailed Description
-----------------
The purpose of this study is to assess the effectiveness of the cloud-based BiovitalsHF® platform to manage initiation and titration of GDMT outside of normal or traditional clinical encounters. The effectives comparison will be to the current standard of care for HF used in the respective clinical sites.

Official Title
-----------------
Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: BiovitalsHF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of heart failure (left ventricular ejection fraction ≤ 40% Must have been diagnosed with HFrEF greater than 3 months HFrEF patients not on optimal GDMT defined as: 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: Absolute Contraindications to GDMT 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 or on transplant list Current or planned Left ventricular assist device Uncontrolled asthma Uncontrolled severe COPD Diagnosed with cirrhosis Currently receiving hospice or comfort care Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study 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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted. | |
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effectiveness of the Biofourmis cloud-based BiovitalsHF™ DTx for GDMT optimization. | 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 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effectiveness of the Biofourmis cloud-based BiovitalsHF™ Dtx to improve clinical outcome. | 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 | To assess the effectiveness of the Biofourmis cloud based BiovitalsHF™ DTx to help improve GDMT adoption and on clinical outcomes | 180 days |