AIM POWER: Artificial Intelligence Mobile Health Trial of a Digital Platform to Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors

  • STATUS
    Recruiting
  • sponsor
    Biofourmis Inc
Updated on 29 November 2022
medical therapy
ejection fraction

Summary

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.

Description

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.

Details
Condition Heart Failure
Clinical Study IdentifierTX310270
SponsorBiofourmis Inc
Last Modified on29 November 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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