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Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT05602454•Duke University

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (7)

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Saint Luke's Health Systems

Kansas City, Missouri, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

December 2, 2022

Primary Completion Date

March 5, 2025

Completion Date

March 5, 2025

Last Updated

July 23, 2025

Enrollment

178

ACTUAL participants

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

Digital Heart Failure Medication Titration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of AI-ECG for SHD Detection

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