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

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