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
- Diseases
- Heart failure
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Ascension St. Vincent Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Saint Luke's Health Systems Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| The University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Cardiovascular Institute of Northwest Florida Coordinator of this site? Confirm its status | Panama City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.