Clinical trial NCT06433687: Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Official title: HeakHeart Phase 1 Proof of Concept Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Heart Failure
Guideline-directed medical therapy
Remote monitoring
Medication optimization
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: HekaHeart
First posted: 2024-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will come from two outpatient Heart Failure clinics associated with Yale New Haven Hospital. The population will be adults ≥18 years with symptomatic HFrEF who are not on adequate GDMT.

Brief summary: This pilot study will test the feasibility of a novel digital health technology-enabled platform, HekaHeart, developed to facilitate comprehensive medical management, including medication initiation, titration, e-prescription eligibility, remote patient monitoring, and communication of care coordination activities, for patients with Heart Failure with Reduced Ejection Fraction (HFrEF) not currently on all four pillars of guideline-directed medical therapy (GDMT).

Detailed description: Heart Failure (HF) is a major cause of morbidity, mortality, and healthcare expenditure in the United States (US). The 2022 AHA/ACC/HFSA Guideline for the management of HF strongly recommends quadruple therapy for all patients with HFrEF, which includes: beta-blockers (BB); renin-angiotensin-aldosterone-system (RAAS) inhibitors such as angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) and angiotensin receptor-neprilysin inhibitors (ARNi); mineralocorticoid receptor antagonists (MRA); and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Unfortunately, suboptimal adoption of GDMT persists despite mounting, unambiguous evidence of its substantial benefit on patient outcomes (including mortality) across numerous large-scale studies.

Further, following initial prescription of quadruple therapy, augmentation of each pillar to target or highest tolerated dosing is critical to achieve maximum benefit, as shown in a recent multinational randomized controlled trial (STRONG-HF) where rapid uptitration to optimal doses of GDMT reduced the risk of death and hospitalization just 180 days after an acute HF episode. Yet, multiple contemporary registry studies continue to reflect suboptimal uptake and dose escalation of GDMT for patients with HFrEF in real-world clinical practice due to both clinical and patient-based barriers.

The HekaHeart platform is a comprehensive remote care and monitoring-based method for GDMT titration and management. The platform uses a virtual team of clinicians with expertise in HF to manage GDMT prescription, dose escalation, and symptom monitoring for patients with HFrEF as a means to both provide personalized patient care and support while alleviating clinician burden. Once a patient is fully optimized with respect to GDMT, they are transitioned back to routine clinical care.

The present study will evaluate the usability of the HekaHeart platform to initiate, monitor, and manage GDMT for patients with HFrEF. The study will prospectively recruit eligible patients from ambulatory HF clinics affiliated with Yale New Haven Health System (YNHHS). Consented patients will be onboarded to the HekaHeart platform for GDMT management by HF disease management clinicians, which will include medication adjustment and remote patient monitoring to assess laboratory results, changes in body weight, blood pressure, and heart rate. Throughout the study, patients will engage in short message service (SMS), video and phone check-ins with clinicians, who will leverage standardized titration protocols to guide medication optimization, monitor patient progress and symptoms, and collect, analyze and respond to remote monitoring data. After 45 days, patients will be transitioned back to usual care.

The primary outcome is the Net Promoter Score (NPS), collected at study offboarding by each participant, and used to assess patient satisfaction with the HekaHeart platform and experience. The secondary outcome is the increase in proportion of HFrEF patients prescribed four pillars of GDMT. Other secondary endpoints include percent of patients successfully onboarded to the HekaHeart platform, proportion of patients whose GDMT is titrated toward target or maximally tolerated dosing, number scheduled visits attended, and percent of platform GDMT recommendations implemented.

Eligibility criteria: Inclusion Criteria:

* Documentation of HFrEF as evidenced by the presence of LVEF ≤40% reading at any time within the last 12 months,

  1. with associated symptoms of HF
  2. or an elevated NT-proBNP
  3. or a hospitalization for HF within the preceding 12 months
* Currently receiving care at YNHHS
* Currently not on all 4 recommended classes of GDMT (BB, ACEi/ARB/ARNi, MRA, and SGLT2i)

Exclusion Criteria:

* Currently pregnant or breast feeding
* Received or listed for cardiac transplantation
* Planned or present durable left ventricular-assist device (LVAD)
* Goals of treatment are palliation
* Currently has a condition(s) that limit survival to \<1 year
* Unable to provide informed consent
* Unwilling to use remote monitoring devices

Primary outcomes:
measure: Net Promoter Score
timeFrame: Assessed at time off patient offboarding (45 days after enrollment)
Secondary outcomes:
measure: Percent of patients on all eligible guideline-directed medical therapy (GDMT) classes
timeFrame: Assessed at time off patient offboarding (45 days after enrollment)
measure: Percent of enrolled patients onboarded to HekaHeart
timeFrame: Assessed from time of enrollment to 45 days post-enrollment
measure: Percent of onboarded patients successfully prescribed a new medication
timeFrame: Assessed from time of enrollment to 45 days post-enrollment
measure: Percent of scheduled study check-ins attended by patients
timeFrame: Assessed from time of enrollment to 45 days post-enrollment
measure: Percent of medication recommendations implemented
timeFrame: Assessed from time of enrollment to 45 days post-enrollment
measure: Time to maximum titration
timeFrame: Assessed from time of enrollment to 45 days post-enrollment
measure: Time from patient enrollment to first remote prescription
timeFrame: Assessed from time of enrollment to 45 days post-enrollment
measure: Ease of implementation of HekaHeart platform
timeFrame: Assessed up to one month post- study completion
Other outcomes:
Locations:
city: Guilford
country: United States
facility: Shoreline Medical Center- 111 Goose Lane location
state: Connecticut
city: New Haven
country: United States
facility: Yale Physicians Building- 800 Howard Ave location
state: Connecticut
Study officials:
affiliation: Yale University
name: Francis P Wilson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: