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

Duke University7 sites in 1 country178 target enrollmentDecember 2, 2022

ConditionsHeart Failure With Reduced Ejection Fraction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure With Reduced Ejection Fraction
Sponsor: Duke University
Enrollment: 178
Locations: 7
Primary Endpoint: Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2, 2022

End Date

March 5, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in medical therapy, as measured by the Heart Failure Medical Therapy Score

Time Frame: Baseline, 6 months

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

Secondary Outcomes

Intensification of evidence-based medical therapies, measured by number of participants with reported changes.(baseline, 6 months)
Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.(6 months)
Change in medical therapy, as measured by the Kansas City Medical Optimization score(Baseline, 6 months)
Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.(6 months)
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence(3 months, 6 months)