Purpose

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.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: 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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control
Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.
Experimental
Intervention
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.
  • Device: BiovitalsHF
    BiovitalsHFTM is a cloud-based platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.

Recruiting Locations

Medstar Union Memorial Hospital
Baltimore, Maryland 21218
Contact:
Sandeep Jani, MD

Medstar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Phillip Lam, MD

More Details

Status
Recruiting
Sponsor
Biofourmis Inc.

Study Contact

Trace Brookins
919.355.8221
trace@biofourmis.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.