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

Duke University

Status: Active, not recruiting

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: Digital Heart Failure Medication Titration

Study type: Interventional

Funder types: Other

Identifiers

NCT05602454

Pro00110400

Details and patient eligibility

About

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

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Digital Heart Failure Medication Titration

Experimental group

Description:

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.

Treatment:

Other: Digital Heart Failure Medication Titration

Usual Care

No Intervention group

Description:

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.