Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors (AIM-POWER)

Biofourmis

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: BiovitalsHF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04191330

BV-EV-HF-1901

Details and patient eligibility

About

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.

Full description

Patients with heart failure (HF) remain at high risk for hospitalization and death in part due to underuse of guideline directed medical therapy (GDMT). Digital interventions may facilitate rapid initiation, titration and optimization of GDMT but have not been systematically evaluated in randomized control trials. In the AIM-POWER study, we evaluated the safety and efficacy of a novel software medical application, BiovitalsHF, as a strategy to guide remote optimization of GDMT in patients with HF with reduced ejection fraction (HFrEF).

Enrollment: 122 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Control

No Intervention group

Description:

Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.

Intervention

Experimental group

Description:

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.

Treatment:

Device: BiovitalsHF