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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Digital Heart Failure Medication Titration

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krista Camuglia; Phone Number: 919-862-5967; Email: krista.camuglia@duke.edu

Study Locations

• United States
  • Florida
    • Panama City, Florida, United States, 32405
      • Recruiting
      • Cardiovascular Institute of Northwest Florida
      • Contact: Shelley Sherk; Phone Number: 850-769-0329; Email: ssherk@cvinwfl.com
      • Principal Investigator: Amir Haghighat, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Ascension St. Vincent
      • Contact: Anne Renick; Phone Number: 317-338-6152; Email: anne.renick@ascension.org
      • Principal Investigator: Sunit-preet Chaudhry
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Medical Center
      • Contact: Becca Johnson; Phone Number: 913-945-6442; Email: bjohnson35@kumc.edu
      • Principal Investigator: Hirak Shah, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Contact: Cailin Oakes; Phone Number: 612-863-5855; Email: cailin.oakes@allina.com
      • Principal Investigator: Mosi Bennett, MD
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Saint Luke's Health Systems
      • Principal Investigator: Andrew Sauer, MD
      • Contact: Amanda Nesbitt; Phone Number: 816-932-7985; Email: anesbitt@saint-lukes.org
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Matthew Gray; Phone Number: 919-681-1073; Email: matthew.gray@duke.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Nancy Albert, PhD; Phone Number: 216-444-7028; Email: albertn@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medical therapy, as measured by the Heart Failure Medical Therapy Score	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	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensification of evidence-based medical therapies, measured by number of participants with reported changes.	Proportion of participants with any intensification of and cumulative number of intensifications of evidence-based medical therapies for HFrEF from baseline to last follow-up.	baseline, 6 months
Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.	The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.	6 months
Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.	The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.	6 months
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence	Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema	3 months, 6 months
Change in medical therapy, as measured by the Kansas City Medical Optimization score	Scores are the average of the total daily dose to target dose values for HF medications. Scores range from 0-100.	Baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participant-reported medication adherence using the Voils score	The Voils score includes questions used to assess medication adherence. Answers range between "not at all" and "very much", with 3 options in between. "Not at all" means a dose was not missed and "Very much" means dose was missed for that reason.	Baseline, 6 months
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score	The Kansas City Cardiomyopathy Questionnaire 12-item version includes multiple domains: symptom frequency, quality of life, social limitation, and physical limitation. The Overall Summary score incorporates the averages of these 4 domains and is reported on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	Baseline, 6 months
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		baseline, 6 months
Composite of all-cause death and total worsening HF events defined by hospitalizations for acute HF and urgent HF events		3 months, 6 months
Worsening HF events defined by hospitalizations for acute HF and urgent HF events		3 months, 6 months
All-cause hospitalizations		3 months, 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Story Health Inc.
• Investigators: Principal Investigator: Adam DeVore, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Pro00110400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No