Want to join the trial?
Choose a location to contact our Clinical Trial Coordinator and to discuss potential opportunities.
Contact to discuss potential opportunities.
Email CoordinatorOverview
AIM POWER: Artificial Intelligence Mobile Health Trial of a Digital Platform to Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors
Description
The goal of this real-world, multi-center, randomized, outpatient study is to assess the effectiveness of the Biofourmis cloud based BiovitalsHF® platform to recommend optimal titration of Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) subjects.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
- 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:
- Use of GDMT less than 50% recommended target dose of at least one HF GDMT
- Use of GDMT at 50% to <100% recommended target doses of two HF GDMTs
Exclusion
- 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