Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients

Heart Failure With Reduced Ejection Fraction Clinical Trial

— HekaHeart POC  

Official title:

HeakHeart Phase 1 Proof of Concept Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433687
• Other study ID #: 2000037817
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Francis P Wilson, MD MSCE
• Phone: 203 7371704
• Email: francis.p.wilson[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Device:
• HekaHeart platform medication management and remote monitoring
Onboarding to the HekaHeart platform which includes a personalized GDMT management plan along with remote monitoring kits including a scale, blood pressure cuff, and heart rate monitor. Patients engage in video and phone calls with clinicians who will use established standardized clinical protocols to guide medication and vital optimization. Once patients are determined to be maximally titrated on all GDMT, they are transitioned back to standard clinical care.

Locations

Country	Name	City	State
United States	Shoreline Medical Center- 111 Goose Lane location	Guilford	Connecticut
United States	Yale Physicians Building- 800 Howard Ave location	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	HekaHeart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net Promoter Score	A metric used to gauge patient satisfaction with the HekaHeart platform. Patients are asked how likely they are to recommend the platform to a friend on a scale of 1 to 10 (with 1 being not likely to recommend, and 10 being highly likely to recommend).	Assessed at time off patient offboarding (45 days after enrollment)
Secondary	Percent of patients on all eligible guideline-directed medical therapy (GDMT) classes	Patients assessed for number of eligible classes of eligible GDMT medications prescribed.	Assessed at time off patient offboarding (45 days after enrollment)
Secondary	Percent of enrolled patients onboarded to HekaHeart	Percent of patients who consented to the study who have successfully onboarded to the HekaHeart plan with an optimized medication management plan.	Assessed from time of enrollment to 45 days post-enrollment
Secondary	Percent of onboarded patients successfully prescribed a new medication	Percent of patients who have been prescribed a new medication within the HekaHeart platform after enrollment.	Assessed from time of enrollment to 45 days post-enrollment
Secondary	Percent of scheduled study check-ins attended by patients	Percent of patients who attended a scheduled check-in (via SMS, text, email, or phone)	Assessed from time of enrollment to 45 days post-enrollment
Secondary	Percent of medication recommendations implemented	Percent of HekaHeart-recommended medications prescribed	Assessed from time of enrollment to 45 days post-enrollment
Secondary	Time to maximum titration	Time in days to optimal titration of all eligible classes of GDMT as determined by clinician judgement and expertise	Assessed from time of enrollment to 45 days post-enrollment
Secondary	Time from patient enrollment to first remote prescription	Time in days to first prescription made in HekaHeart platform	Assessed from time of enrollment to 45 days post-enrollment
Secondary	Ease of implementation of HekaHeart platform	Determined via qualitative survey assessment of clinicians which asks how well the HekaHeart platform integrates into existing systems and workflows	Assessed up to one month post- study completion