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NCT05602454Completed

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

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

Source: ClinicalTrials.gov · Last updated 23 Jul 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
178 (actual)
First submitted
27 Oct 2022
Start date
2 Dec 2022
Primary completion date
5 Mar 2025
Lead sponsor
Duke University
NCT number
NCT05602454

What you commit to

  • Study type: Interventional
  • Participants enrolled: 178
  • From 2 Dec 2022 to the primary completion date, 5 Mar 2025
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Optimized or nearly-optimized on evidence-based medical therapies for HFrEF as determined by local investigator.
  • Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
  • Prior heart transplant
  • Currently receiving hospice care
  • Chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel

Other illness

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

Lab values

  • eGFR of \<20 mL/min/1.73m2 or ongoing chronic dialysis at screening

Other

  • Current pregnancy
  • Current or planned left ventricular assist device

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Ascension St. Vincent
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Saint Luke's Health Systems
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
The University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Minneapolis Heart Institute Foundation
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Cardiovascular Institute of Northwest Florida
Coordinator of this site? Confirm its status
Panama CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.