Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors
Trial ID: NCT04191330
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2020-01-27
Completion date: 2024-08-31
Sponsor: Biofourmis Inc.
Conditions: Heart Failure
Interventions: BiovitalsHF
Locations: Cardiology and Medicine Clinic; Medstar Washington Hospital Center; Piedmont Athens Regional Medical Center; Baptist Health Louisville Heart Failure Clinic; Cambridge Medical Trials; Medstar Union Memorial Hospital; St Joseph Mercy; Jackson Heart; University of Medical Center of Southern Nevada; Rutgers Robert Wood Johnson Medical School; Premier Cardiovascular Institute; Providence St Vincent Medical Center; University of Tennessee Medical Center; Austin Heart
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 122
Age range: 22 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

Subjects are eligible to be included in the study only if all the following criteria apply:

* Written informed consent must be obtained before any assessment is performed
* Age ≥ 22 years at signing of informed consent
* Diagnosis of heart failure with left ventricular ejection fraction ≤ 40%, EF can be assessed by any validated method, but assessment must have occurred within the last year.
* HFrEF patient not on optimal GDMT defined as:

Participant not on optimal GDMT for HFrEF per investigator judgement. 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.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

Therapy related

* Absolute contraindications to HF GDMT Disease related
* Heart failure hospitalization in the past 28 days.
* 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 transplant or on transplant list
* Current or planned left ventricular assist device Comorbidity or other medical conditions
* Uncontrolled asthma
* Active wheezing on physical exam
* Uncontrolled severe COPD
* Diagnosed with cirrhosis
* Currently being treated for active malignancy and life expectancy is less than one year
* Currently receiving hospice or comfort care Prior or concurrent clinical study experience
* Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study Other General Exclusions
* 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

Outcomes:
• To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTx to improve guideline-directed medical therapy (GDMT) adoption in subjects with heart failure with reduced ejection fraction (HFrEF) after 90 days of using the platform