Virtual cardiology program for improving heart failure outcomes
Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial
This study is testing a virtual heart care program to see if it helps people with heart failure feel better and manage their symptoms after leaving the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Gainesville, Georgia and 1 other locations) |
| Trial ID | NCT06592508 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a remote virtual cardiology program designed to provide education and monitoring for patients with acute decompensated heart failure. Participants will receive tailored heart failure education, ongoing monitoring for worsening symptoms, and timely adjustments to their medications. The program will be compared to standard care practices to determine its impact on patient outcomes following hospitalization for heart failure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for acute decompensated heart failure.
Not a fit: Patients who are already optimized on heart failure medications or those with severe renal impairment may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could lead to improved management of heart failure and reduced hospital readmissions for patients.
How similar studies have performed: Other studies have shown promising results with virtual care approaches in managing chronic conditions, suggesting potential success for this program.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years of age * Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF. * Fluent in written and spoken English Exclusion Criteria: * Optimized or nearly optimized on evidence-based medical therapies for HF 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 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation. * History of prior heart transplant or currently listed for heart transplant * Current left ventricular assist device or planned left ventricular assist device in the next 6 months * Currently receiving hospice care * Chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel * Terminal illness other than HF with a life expectancy of \<1 year as determined by the enrolling clinician-investigator
Where this trial is running
Gainesville, Georgia and 1 other locations
- Northeast Georgia Medical Center — Gainesville, Georgia, United States (Recruiting)
- Duke Raleigh Hospital — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Adam DeVore — Duke University
- Study coordinator: Project Manager
- Email: ELEVATE-HF@duke.edu
- Phone: 919-862-5967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.