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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-02

Study Completion Date

2025-03-05

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

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Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Heart Failure Medication Titration

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.

Group Type EXPERIMENTAL

Digital Heart Failure Medication Titration

Intervention Type OTHER

Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.

Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Heart Failure Medication Titration

Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No