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

NCT05602454 | Completed

• 1 other identifier: Pro00110400
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 7

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

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in medical therapy, as measured by the Kansas City Medical Optimization score

  Baseline, 6 months

• Intensification of evidence-based medical therapies, measured by number of participants with reported changes.

  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

• Proportion of participants on 100% 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

Other Outcomes (6)

• Change in participant-reported medication adherence using the Voils score

  Baseline, 6 months

• Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score

  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

Study Arms (2)

Digital Heart Failure Medication Titration

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Digital Heart Failure Medication Titration OTHER

Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.

Digital Heart Failure Medication Titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Story Health Inc.: collaborator

Study Sites (7)

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32405, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46260, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Saint Luke's Health Systems

Kansas City, Missouri, 64111, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Khan MS, Sauer AJ, Green CL, McDermott J, Khan MS, Chaudhry SP, Haghighat AR, Bennett MK, Martyn T, Shah H, Govil A, Stanis T, Albert NM, DeVore AD. Rationale, design, and baseline characteristics of the virtual care to improve heart failure outcomes (VITAL-HF) trial. Am Heart J. 2025 Dec;290:46-57. doi: 10.1016/j.ahj.2025.06.001. Epub 2025 Jun 3.

  PMID: 40473009 DERIVED

Study Officials

• Adam DeVore, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: December 2, 2022
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)