## Protocol Section
### Identification Module
**NCT ID:** NCT06433687

**Acronym:** HekaHeart POC

**Brief Title:** HekaHeart Phase 1 Proof of Concept

**Official Title:** HeakHeart Phase 1 Study: Proof of Concept

#### Organization Study ID Info
**ID:** 2000037817
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Roivant Sciences (HekaHeart)

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Heart Failure With Reduced Ejection Fraction

**Keywords:**

- Heart Failure

- Guideline-directed medical therapy

- Remote monitoring

- Medication optimization

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: HekaHeart platform medication management and remote monitoring

**Label:** HekaHeart-based medication optimization and remote monitoring

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HekaHeart-based medication optimization and remote monitoring

**Description:** 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.

**Name:** HekaHeart platform medication management and remote monitoring

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Net Promoter Score

**Time Frame:** Assessed at time off patient offboarding (45 days after enrollment)

#### Secondary Outcomes

**Description:** Patients assessed for number of eligible classes of eligible GDMT medications prescribed.

**Measure:** Percent of patients on all eligible guideline-directed medical therapy (GDMT) classes

**Time Frame:** Assessed at time off patient offboarding (45 days after enrollment)

**Description:** Percent of patients who consented to the study who have successfully onboarded to the HekaHeart plan with an optimized medication management plan.

**Measure:** Percent of enrolled patients onboarded to HekaHeart

**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment

**Description:** Percent of patients who have been prescribed a new medication within the HekaHeart platform after enrollment.

**Measure:** Percent of onboarded patients successfully prescribed a new medication

**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment

**Description:** Percent of patients who attended a scheduled check-in (via SMS, text, email, or phone)

**Measure:** Percent of scheduled study check-ins attended by patients

**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment

**Description:** Percent of HekaHeart-recommended medications prescribed

**Measure:** Percent of medication recommendations implemented

**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment

**Description:** Time in days to optimal titration of all eligible classes of GDMT as determined by clinician judgement and expertise

**Measure:** Time to maximum titration

**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment

**Description:** Time in days to first prescription made in HekaHeart platform

**Measure:** Time from patient enrollment to first remote prescription

**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment

**Description:** Determined via qualitative survey assessment of clinicians which asks how well the HekaHeart platform integrates into existing systems and workflows

**Measure:** Ease of implementation of HekaHeart platform

**Time Frame:** Assessed up to one month post- study completion

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** francis.p.wilson@yale.edu

**Name:** Francis P Wilson, MD MSCE

**Phone:** 203 7371704

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guilford

**Contacts:**

***Contact 1:***

- **Email:** marc.samsky@yale.edu

- **Name:** Marc Samsky, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** Shoreline Medical Center- 111 Goose Lane location

**State:** Connecticut

**Zip:** 06437

**Location 2:**

**City:** New Haven

**Contacts:**

***Contact 1:***

- **Email:** marc.samsky@yale.edu

- **Name:** Marc Samsky, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** Yale Physicians Building- 800 Howard Ave location

**State:** Connecticut

**Zip:** 06519

#### Overall Officials

**Official 1:**

**Affiliation:** Yale University

**Name:** Francis P Wilson, MD MSCE

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** De-identified data for the primary and secondary outcomes will be made available upon publication.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Data will become available upon publication and indefinitely.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
