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

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 beassessed by any validated method, but assessment must have occurred within the lastyear.

• 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 <30mL/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 medicalconditions

• 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 oneyear

• Currently receiving hospice or comfort care Prior or concurrent clinical studyexperience

• Currently participating or receiving treatment in an investigational device orinvestigational drug study while participating in this study Other GeneralExclusions

• 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 orprocedures, and/or to comply with all required study procedures (e.g., ClinicalOutcome Assessments) to the best of the subject and investigator's knowledge.

• History or evidence of any other clinically significant disorder, condition, ordisease (with the exception of those outlined above) that, in the opinion of theinvestigator or Biofourmis medical monitor, if consulted, would pose a risk tosubject safety or interfere with the study evaluation, procedures or completion.

• Subject has diminished decision making capability