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

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