Clinical trial NCT04191330: Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors
Official title: Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Biofourmis Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-09
Enrollment: 122
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: • 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
timeFrame: 90 days
Secondary outcomes:
measure: • To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTX to improve the composite clinical outcome by calculating the win ratio between treatment and control arm.
timeFrame: 90 days
measure: • To assess the effectiveness of the Biofourmis cloud based BiovitalsHF DTx to help improve GDMT adoption and on clinical outcomes.
timeFrame: 90 days
measure: GDMT initiation
timeFrame: 90 days
measure: Quadruple therapy
timeFrame: 90 days
measure: Time to GDMT optimization
timeFrame: 90 days
measure: Change in biomarkers
timeFrame: 90 days
measure: Safety outcomes
timeFrame: 90 days
Other outcomes:
measure: Change in quality of life and function
timeFrame: 90 days
Locations:
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic
state: Arkansas
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Louisville
country: United States
facility: Baptist Health Louisville Heart Failure Clinic
state: Kentucky
city: Alexandria
country: United States
facility: Cambridge Medical Trials
state: Louisiana
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Ypsilanti
country: United States
facility: St Joseph Mercy
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart
state: Mississippi
city: Las Vegas
country: United States
facility: University of Medical Center of Southern Nevada
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Dayton
country: United States
facility: Premier Cardiovascular Institute
state: Ohio
city: Portland
country: United States
facility: Providence St Vincent Medical Center
state: Oregon
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: San Marcos
country: United States
facility: Austin Heart
state: Texas
Study officials:
affiliation: Brigham and Womens Hospital
name: Akshay Desai, MD
role: STUDY_CHAIR
affiliation: Duke Clinical Research Institute
name: Adam Devore, MD
role: PRINCIPAL_INVESTIGATOR
References: