Clinical trial NCT05602454: Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
Official title: Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Story Health Inc.
First posted: 2022-11-02
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in medical therapy, as measured by the Kansas City Medical Optimization score
timeFrame: Baseline, 6 months
measure: Intensification of evidence-based medical therapies, measured by number of participants with reported changes.
timeFrame: baseline, 6 months
measure: Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
timeFrame: 6 months
measure: Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
timeFrame: 6 months
measure: Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence
timeFrame: 3 months, 6 months
Other outcomes:
measure: Change in participant-reported medication adherence using the Voils score
timeFrame: Baseline, 6 months
measure: Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score
timeFrame: Baseline, 6 months
measure: Global rank score across 3 hierarchical tiers of a composite outcome: time to death, time to HF hospitalization, change from baseline to last follow-up in the HF medical therapy score
timeFrame: baseline, 6 months
measure: Composite of all-cause death and total worsening HF events defined by hospitalizations for acute HF and urgent HF events
timeFrame: 3 months, 6 months
measure: Worsening HF events defined by hospitalizations for acute HF and urgent HF events
timeFrame: 3 months, 6 months
measure: All-cause hospitalizations
timeFrame: 3 months, 6 months
Locations:
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Indianapolis
country: United States
facility: Ascension St. Vincent
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Health Systems
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Duke University
name: Adam DeVore, MD
role: PRINCIPAL_INVESTIGATOR
References: