Clinical trial NCT06592508: Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure
Official title: Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure; With Decompensation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Ventricle Health
First posted: 2024-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.


Eligibility 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

Primary outcomes:
measure: Time to all-cause death
timeFrame: Up to 120 days
measure: Number of participants with worsening Heart Failure events
timeFrame: Up to 120 days
measure: Time to first worsening Heart Failure event
timeFrame: Up to 120 days
measure: Change in the number of classes of Heart Failure medications
timeFrame: Up to 120 days
Secondary outcomes:
measure: Number of participants with any intensification (initiation or dose titration) of evidence-based medical therapies for HF (heart failure)
timeFrame: Baseline, 120 days
measure: Cumulative number of intensifications of evidence-based medical therapies for HF (heart failure)
timeFrame: Baseline, 120 days
measure: Change in the number of classes of HF (heart failure) medications
timeFrame: Baseline, 120 days
measure: Composite of all-cause death and total worsening HF (heart failure) events defined by hospitalizations for acute decompensated HF and other urgent medical care for worsening HF
timeFrame: 30 day, 60 day, 120 day
measure: Number of participants with combined Emergency department visits and hospitalizations
timeFrame: 30 day, 60 day, 120 day
Other outcomes:
measure: Change in participant-reported medication adherence using the Voils score
timeFrame: Baseline, 120 day
measure: Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score
timeFrame: Baseline, 120 day
measure: Net promoter score as assessed by the Ventricle Health Performance Survey
timeFrame: 120 day
measure: Number of participants with All-cause hospitalization
timeFrame: 30 day, 60 day, 120 day
Locations:
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Adam DeVore
role: PRINCIPAL_INVESTIGATOR
References: