Heart Failure; With Decompensation
Conditions
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.
Interventions
OTHERRemote Virtual Cardiology Program
Ventricle Health Program, which is a remote, virtual, cardiology program that provides heart failure education to patients, monitors for worsening heart failure, and rapidly titrates heart failure medical therapy.
Sponsors
Duke University
Ventricle Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to all-cause death | Up to 120 days |
| Number of participants with worsening Heart Failure events | Up to 120 days |
| Time to first worsening Heart Failure event | Up to 120 days |
| Change in the number of classes of Heart Failure medications | Up to 120 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with any intensification (initiation or dose titration) of evidence-based medical therapies for HF (heart failure) | Baseline, 120 days | — |
| Cumulative number of intensifications of evidence-based medical therapies for HF (heart failure) | Baseline, 120 days | — |
| Change in the number of classes of HF (heart failure) medications | Baseline, 120 days | by different HF classifications as defined by LVEF |
| 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 | 30 day, 60 day, 120 day | — |
| Number of participants with combined Emergency department visits and hospitalizations | 30 day, 60 day, 120 day | Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HF including symptomatic hypotension, hyperkalemia, and angioedema. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam DeVore
Duke University
Outcome results
None listed