Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction

Official Title
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Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) Randomized Controlled Trial

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Other: Digital Heart Failure Medication Titration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years of age Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year prior to screening. Any validated method for assessing LVEF may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. For participants with an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an LVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. The enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset HFrEF. Access to a smartphone including through a family member of caregiver Fluent in written and spoken English Exclusion Criteria: Optimized or nearly-optimized on evidence-based medical therapies for HFrEF as determined by local investigator. Current pregnancy Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine eGFR of <20 mL/min/1.73m2 or ongoing chronic dialysis at screening Prior heart transplant Current or planned left ventricular assist device Currently receiving hospice care Chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel Terminal illness other than HF with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Heart Failure Medication Titration<br>The Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc. | Other: Digital Heart Failure Medication Titration<br>* Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.<br>|
| No Intervention: Usual Care<br>Routine clinical care will be followed. Participants will also receive a blood pressure cuff and scale, though the data will not be routinely fed back to the treating clinicians unless requested. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medical therapy, as measured by the Heart Failure Medical Therapy Score | Scores are 0-3 for 7 key medication classes for heart failure with reduced ejection fraction where 0 represents no use of the medication class | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensification of evidence-based medical therapies, measured by number of participants with reported changes. | Proportion of participants with any intensification of and cumulative number of intensifications of evidence-based medical therapies for HFrEF from baseline to last follow-up. | baseline, 6 months | 
| Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up. | The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines. | 6 months | 
| Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up. | The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines. | 6 months | 
| Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence | Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema | 3 months, 6 months |