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

NCT06433687 | Withdrawn

• 1 other identifier: 2000037817
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart Failure; Guideline-directed medical therapy; Remote monitoring; Medication optimization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percent of patients on all eligible guideline-directed medical therapy (GDMT) classes

  Assessed at time off patient offboarding (45 days after enrollment)

• Percent of enrolled patients onboarded to HekaHeart

  Assessed from time of enrollment to 45 days post-enrollment

• Percent of onboarded patients successfully prescribed a new medication

  Assessed from time of enrollment to 45 days post-enrollment

• Percent of scheduled study check-ins attended by patients

  Assessed from time of enrollment to 45 days post-enrollment

• Percent of medication recommendations implemented

  Assessed from time of enrollment to 45 days post-enrollment

Study Arms (1)

HekaHeart-based medication optimization and remote monitoring

Patients will onboard to the HekaHeart platform, which will recommend a GDMT management plan that has been validated by a Yale-based clinician, with consideration given to eligibility for GDMT, past medical history, and patient preference. Participants will also be provided with an at-home blood pressure cuff, weight scale, and heart rate monitor and be instructed to use these devices on a regular cadence. Measurements will be electronically transmitted in real-time to the HekaHeart platform and uploaded to a web-based portal for review. Weekly/bi-weekly scheduled remote check-ins will be used by clinicians to monitor patient progress with GDMT management, to evaluate whether additional medications or dose adjustments are necessary, monitor symptoms, identify issues, offer medical education, and provide continued assistance with remote patient monitoring (RPM) devices. A final patient offboarding visit will occur once the patient has been on the platform for 45 days.

Device: HekaHeart platform medication management and remote monitoring

Interventions

HekaHeart platform medication management and remote monitoring DEVICE

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.

HekaHeart-based medication optimization and remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Documentation of HFrEF as evidenced by the presence of LVEF ≤40% reading at any time within the last 12 months,
• with associated symptoms of HF
• or an elevated NT-proBNP
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• HekaHeart: collaborator

Study Sites (2)

Shoreline Medical Center- 111 Goose Lane location

Guilford, Connecticut, 06437, United States

Location

Yale Physicians Building- 800 Howard Ave location

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Francis P Wilson, MD MSCE

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available upon publication and indefinitely.

Locations

US (2)