Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
NCT06433687 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2025-08-17
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
Interventions
- 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.
Sponsors & Collaborators
-
HekaHeart
collaborator UNKNOWN -
Yale University
lead OTHER
Principal Investigators
-
Francis P Wilson, MD MSCE · Yale University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-31
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
Countries
- United States
Study Locations
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