Status:
RECRUITING
Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure
Lead Sponsor:
Duke University
Collaborating Sponsors:
Ventricle Health
Conditions:
Heart Failure; With Decompensation
Eligibility:
All Genders
18+ years
Phase:
NA
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 qu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06592508
Start Date
September 27 2024
End Date
August 1 2026
Last Update
October 21 2025
Active Locations (5)
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1
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States, 32405
2
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
3
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
4
Premier Health
Dayton, Ohio, United States, 45409