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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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.
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
• 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
The primary endpoint will be the between-group difference in the change at 90 days, between the intervention and control arm in heart failure optimal therapy score. Heart Failure Optimal Therapy Score: A heart failure optimal therapy score was developed (see Table S9 below) based on clinical practice guidelines, including the 2021 Update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment {REF}. One point is awarded for initiating evidence-based BB, MRA, or ARNI and two points for up titrating those classes of medications to 50% or higher target dose. Two points are awarded for initiating SGLT2 inhibitor as there is a single approved dose (and no opportunity for dose titration). Finally, if a patient is not on an ARNI, one point is awarded for ACEi/ARB at 50% or higher target dose. Of note, ARNI patients do not receive points for ACEi/ARB. The maximum possible score is 8 points, and the minimum possible score is 0 points.
Time frame: 90 days
• 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.
A win ratio \[13\] will be used to analyze the composite endpoints in the following order of clinical importance: * Time to CV death * Time to heart failure related hospitalization * Improvement in GDMT score * Improvement in KCCQ score * Reduction on NTproBNP by 30% compared to baseline (TABLE 3)
Time frame: 90 days
• To assess the effectiveness of the Biofourmis cloud based BiovitalsHF DTx to help improve GDMT adoption and on clinical outcomes.
• The key secondary endpoint will be the percentage of subjects on target dose of GDMT. Comparisons between the control and intervention arm will be based on the CHAMP-HF registry design \[4\]. At baseline, day 90, and day 180, subjects will be divided into one of four groups according to prescribed dose of GDMT: subjects not receiving medication, subjects treated with \<50% target dose, subjects treated with 50 to \<100% target dose, and subjects treated with \>100% target dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
Baptist Health Louisville Heart Failure Clinic
Louisville, Kentucky, United States
Cambridge Medical Trials
Alexandria, Louisiana, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
St Joseph Mercy
Ypsilanti, Michigan, United States
Jackson Heart
Jackson, Mississippi, United States
University of Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
...and 4 more locations
Time frame: 90 days
GDMT initiation
• Initiation of evidence-based beta-blocker, ACEi/ARB/ARNI, MRA or SGLT2 inhibitors including proportion of subjects switching from ACEi/ARB to ARNI
Time frame: 90 days
Quadruple therapy
• Proportion of subjects on 4 GDMT drug classes
Time frame: 90 days
Time to GDMT optimization
• Time taken to achieve 50% target dose between control and intervention arms.
Time frame: 90 days
Change in biomarkers
• Change in NT-pro-BNP
Time frame: 90 days
Safety outcomes
* Incidence of worsening renal function (i.e., defined as an increase in serum creatinine \> 0.5 mg/dl) * Incidence of symptomatic postural hypotension (defined as dizziness, lightheadedness, or syncope due to low blood pressure) * Objective evidence of hypotension (SBP \< 90 mmHg) * Incidence of hyperkalemia (i.e., defined K ≥ \_\_5.5 mEq/L) * Incidence of angioedema * Incidence of severe bradycardia (i.e., defined as an average heart rate \< 50 bpm for 12 hours in one day or for 4 contiguous hours)
Time frame: 90 days