Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure (ELEVATE-HF)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; With Decompensation
• Intervention / Treatment: Other: Remote Virtual Cardiology Program

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Panama City, Florida, United States, 32405
      • Cardiovascular Institute of Northwest Florida
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Duke Raleigh Hospital
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Premier Health
    • Toledo, Ohio, United States, 43615
      • ProMedica Toledo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Remote Virtual Cardiology Program; The Ventricle Health program will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. In addition, the program will also remotely receive oxygen levels and electrical heart activity directly from a Pulse Ox and an EKG Single-Lead monitor, provided to the participant. All of this data will be transmitted to the Ventricle Health program. The Ventricle Health team, consisting of Cardiologists and clinical staff, will use this data to titrate medications and make clinical decisions.	Other: Remote 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.
No Intervention: Usual Care; Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	by different HF classifications as defined by LVEF	Baseline, 120 days
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	Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HF including symptomatic hypotension, hyperkalemia, and angioedema.	30 day, 60 day, 120 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participant-reported medication adherence using the Voils score	The Voils score includes questions used to assess medication adherence. Answers range between "not at all" and "very much", with 3 options in between. "Not at all" means a dose was not missed and "Very much" means dose was missed for that reason.	Baseline, 120 day
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score	The Kansas City Cardiomyopathy Questionnaire 12-item version includes multiple domains: symptom frequency, quality of life, social limitation, and physical limitation. The Overall Summary score incorporates the averages of these 4 domains and is reported on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	Baseline, 120 day
Net promoter score as assessed by the Ventricle Health Performance Survey		120 day
Number of participants with All-cause hospitalization		30 day, 60 day, 120 day

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Ventricle Health
• Investigators: Principal Investigator: Adam DeVore, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2024
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: Pro00115672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No