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

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

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

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