ACTIVE_NOT_RECRUITING

Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial

Quick Facts

Study Start:2024-09-27

Study Completion:2026-02-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06592508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Adam DeVore

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32405

United States

Northeast Georgia Medical Center

Gainesville, Georgia, 30501

United States

Duke Raleigh Hospital

Raleigh, North Carolina, 27609

United States

Premier Health

Dayton, Ohio, 45409

United States

ProMedica Toledo Hospital

Toledo, Ohio, 43615

United States

Collaborators and Investigators

Sponsor: Duke University

Adam DeVore, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-27

Study Completion Date2026-02-10

Study Record Updates

Study Start Date2024-09-27

Study Completion Date2026-02-10

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure; With Decompensation