Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors
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.
- Heart Failure
- Eligible Ages
- Over 22 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Diagnosis of heart failure (left ventricular ejection fraction ≤ 40% - New York Heart Association (NYHA) class II-III at most recent screening assessment - HFrEF patients not on GDMT defined as: 1. Use of GDMT less than 50% recommended target dose of at least one HF GDMT 2. Use of GDMT at 50% to <100% recommended target doses of two HF GDMTs
- 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 - 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
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.||
|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.||
- Biofourmis Inc.
Study ContactTrace Brookins
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.