Heart Failure Clinical Trial
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.
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.
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
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 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
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There are 14 Locations for this study
Little Rock Arkansas, 72204, United States More Info
Washington District of Columbia, 20010, United States More Info
Athens Georgia, 30306, United States More Info
Louisville Kentucky, 40207, United States More Info
Alexandria Louisiana, 71301, United States More Info
Baltimore Maryland, 21218, United States More Info
Ypsilanti Michigan, 48197, United States More Info
Jackson Mississippi, 39216, United States More Info
Las Vegas Nevada, 89102, United States More Info
New Brunswick New Jersey, 08901, United States More Info
Dayton Ohio, 45414, United States More Info
Portland Oregon, 97225, United States More Info
Knoxville Tennessee, 37920, United States More Info
San Marcos Texas, 78666, United States More Info
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