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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Page 1 of 2 (5 locations)

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