Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-23
Brief Title:
Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
HeakHeart Phase 1 Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HekaHeart POC
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 AHAACCHFSA 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None