Background/Rationale:
Guideline-directed medical therapy (GDMT) is a cornerstone of the management of
individuals with heart failure with reduced ejection fraction (HFrEF). Patients on
optimal heart failure pharmacotherapy experience higher survival rates and fewer heart
failure hospitalizations compared with subjects not on these medications [1,2].
Furthermore, optimal compliance with these treatments among patients with heart failure
is associated with fewer have fewer emergency department visits, fewer hospital
admissions, shorter lengths of hospital stay, and lower risk of death [3,4].
Despite very strong evidence for these treatments, a substantial proportion of eligible
subjects with HFrEF are not on GDMT at optimal dosages. Data from the CHAMP-HF registry
demonstrate that fewer than one in four HFrEF subjects are on all three of GDMT
medications - beta-blockers; angiotensin-converting enzyme inhibitor (ACEi)/angiotensin
II receptor blocker (ARB), or angiotensin receptor neprilysin inhibitor (ARNI); and
mineralocorticoid receptor antagonist (MRA) - and only 1% were receiving target doses of
all three medications [4]. Published data for both UT-Southwestern and Parkland Health
System have demonstrated that rates of GDMT are above national averages but remain
suboptimal with significant room for improvement.
Successful interventions to increase the number of subjects of prescribed GDMT at optimal
doses often have included multidisciplinary heart failure clinics that include advanced
practice providers and/or pharmacists with frequent visits [5,6]. However, such
strategies are resource-intensive and are not widely applicable to heart failure
management outside of specialized heart failure clinics. Health systems, such as Parkland
Health System and UT-Southwestern, have also considered and purchased remote home
monitoring programs for patients with systolic heart failure to try to improve
prescription rates of GDMT. However, few studies have evaluated the impact of remote home
monitoring on rates of GDMT in highly diverse patient populations or patients with
increased socioeconomic risk.
As such, there is a crucial unmet need to implement highly effective GDMT titration
strategies in heart failure populations with increased socioeconomic risk and the effects
of remote monitoring systems to improve GDMT are not well known.
To address this gap in knowledge, we will leverage the large, multiethnic heart failure
populations followed in two health systems, UT-Southwestern and Parkland Health System.
Using these racially and ethnically diverse patient populations, we will test our central
hypothesis that the AHA Digital Platform will improve outcomes in patients with HFrEF by
managing the initiation and titration of heart failure GDMT in comparison with clinical
care. The purpose of this study is to assess the effectiveness of the remote monitoring
AHA Digital Platform to improve initiation and titration of GDMT in addition to
traditional clinical encounters. The effective comparison will be to the current standard
of care for heart failure used in the respective clinical sites.
The AHA Digital platform integrates data from remote wireless vital signs collection
devices and an investigational wearable health device to recommend optimal titration of
GDMT in subjects with heart failure with reduced ejection fraction (HFrEF) subjects or
HFrEF subjects on suboptimal doses of GDMT. The platform uses a proprietary algorithm to
interpret the remote vitals data collected and presents titration recommendations back to
the healthcare provider (HCP) via a HCP mobile App for subjects randomized to the
Intervention Arm at his/her site. Vitals data and relevant HF educational materials are
simultaneously presented to the subject via a Patient App. Data from an investigational
wearable health device is also provided to both the HCP and subject, however no care
decisions are made with the data from this device. The HCP is also alerted to changes in
status of the respective participating trial subjects via the HCP App and can see
aggregated information and further visualize the status of all subjects enrolled in
his/her center via an online web portal.
Hypothesis We hypothesize that use of the AHA Digital Solution in a real-world,
multi-site, randomized, outpatient study will improve rates and does of optimal
Guideline-Directed Medical Therapy (GDMT) for patients with heart failure with reduced
ejection fraction.
