Clinical trial NCT05988749: Digital Remote Home Monitoring for Heart Failure
Official title: American Heart Association Digital Home Remote Monitoring for Heart Failure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: remote home monitoring
heart failure
guideline directed medical therapy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be randomized in a 1:2 fashion to usual care versus usual care plus the American Heart Association's Digital Solution by dice roll.
Primary purpose: SUPPORTIVE_CARE

Brief summary: We will enroll 150 adult participants with systolic heart failure into the ADHERE-HF trial. The study will randomize participants in a 1:2 fashion to usual care or usual care plus the American Heart Association's Digital Solution for 90 days. This wearable device and careplan package is hypothesized to improve rates of guideline directed heart failure medical care for participants.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥18-year-old adults with a clinical diagnosis of heart failure AND a left ventricular ejection fraction ≤40% by transthoracic echocardiogram or cardiac MRI within 12 months prior to enrollment.

Exclusion Criteria:

* Patients who are pregnant.
* Patients who do not have a smartphone or access to the Internet
* Prisoners or refugees.
* Patients who are homeless or have unstable housing.
* Unable or unwilling to consent or use study related materials.
* On-going cocaine, methamphetamine, opioid, alcohol, or other illicit substance abuse as determined by the study PI.
* Not fluent in English or Spanish.
* Students or trainees at UT-Southwestern or Parkland Health System.
* Enrolled or considering hospice.
* Recent or home inotropic therapy, or heart transplant evaluation.
* Survival anticipated \<6 months.
* End-stage renal disease, receiving dialysis or eGFR ≤30 mL/min/1.73m2
* Non-Texas resident

Primary outcomes:
measure: GDMT score
timeFrame: 0-90 days
Secondary outcomes:
measure: Hospitalized days
timeFrame: 0-90 days; 0-180 days
measure: Emergency room visits
timeFrame: 0-90 days; 0-180 days
measure: GDMT score
timeFrame: 0-180 days
measure: Change in KCCQ-12 score
timeFrame: day 0-90 and 0-180
measure: Visual analog score change
timeFrame: day 0-90
measure: Optimal GDMT dosing
timeFrame: 0-90 days, 0-180 days
Other outcomes:
measure: Patient encounters
timeFrame: 0-90; 0-180 days
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Nicholas Hendren, MD
role: PRINCIPAL_INVESTIGATOR
References: