American Heart Association Digital Home Remote Monitoring for Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- GDMT score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Device
Participants will receive usual care or usual care plus the American Heart Association's Digital Solution in patients with HFrEF. The Solution is a combination of the AHA/CHTI HF CarePlans and Education Content, delivered through and combined with the Biofourmis Platform.
Intervention: Biofourmis Digital Platform (Other)
Routine Care
Routine care for heart failure management
Outcomes
Primary Outcomes
GDMT score
Time Frame: 0-90 days
Change in GDMT score from between the intervention and control arm.
Secondary Outcomes
- Visual analog score change(day 0-90)
- Emergency room visits(0-90 days; 0-180 days)
- Change in KCCQ-12 score(day 0-90 and 0-180)
- Hospitalized days(0-90 days; 0-180 days)
- GDMT score(0-180 days)
- Optimal GDMT dosing(0-90 days, 0-180 days)
Investigators
Nicholas Hendren
Assistant Professor of Medicine
University of Texas Southwestern Medical Center