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

Last updated: October 18, 2024
Sponsor: Duke University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Failure

Hyponatremia

Treatment

Digital Heart Failure Medication Titration

Clinical Study ID

NCT05602454
Pro00110400
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age >18 years of age

  • Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year priorto screening. Any validated method for assessing LVEF may be used for enrollmentincluding echocardiogram, cardiac magnetic resonance imaging, etc. For participantswith an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range onthe most recent imaging assessment that includes 40% (e.g., 35-45%), then the siteinvestigator should review the imaging study and determine if the participant has anLVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. Theenrollment will be monitored to ensure no more than 50% of the total cohort havenew-onset HFrEF.

  • Access to a smartphone including through a family member of caregiver

  • Fluent in written and spoken English

Exclusion

Exclusion Criteria:

  • Optimized or nearly-optimized on evidence-based medical therapies for HFrEF asdetermined by local investigator.

  • Current pregnancy

  • Chronic use of intravenous inotropic medications including milrinone, dobutamine, ordopamine

  • 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 andmedications are managed by facility personnel

  • Terminal illness other than HF with a life expectancy of less than 1 year asdetermined by the enrolling clinician-investigator

Study Design

Total Participants: 178
Treatment Group(s): 1
Primary Treatment: Digital Heart Failure Medication Titration
Phase:
Study Start date:
December 02, 2022
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida 32405
    United States

    Site Not Available

  • Ascension St. Vincent

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Saint Luke's Health Systems

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

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