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Completed

NCT Number: NCT06592508

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute of Northwest Florida, Panama City, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Virtual Cardiology Program

Other

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.

Primary outcomes

  1. Time to all-cause death

    Time frame: Up to 120 days

  2. Number of participants with worsening Heart Failure events

    Time frame: Up to 120 days

  3. Time to first worsening Heart Failure event

    Time frame: Up to 120 days

  4. Change in the number of classes of Heart Failure medications

    Time frame: Up to 120 days

Secondary outcomes

  1. Number of participants with any intensification (initiation or dose titration) of evidence-based medical therapies for HF (heart failure)

    Time frame: Baseline, 120 days

  2. Cumulative number of intensifications of evidence-based medical therapies for HF (heart failure)

    Time frame: Baseline, 120 days

  3. Change in the number of classes of HF (heart failure) medications

    Time frame: Baseline, 120 days

    by different HF classifications as defined by LVEF

  4. 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

    Time frame: 30 day, 60 day, 120 day

  5. Number of participants with combined Emergency department visits and hospitalizations

    Time frame: 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.

Other outcomes

  1. Change in participant-reported medication adherence using the Voils score

    Time frame: Baseline, 120 day

    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.

  2. Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score

    Time frame: Baseline, 120 day

    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.

  3. Net promoter score as assessed by the Ventricle Health Performance Survey

    Time frame: 120 day

  4. Number of participants with All-cause hospitalization

    Time frame: 30 day, 60 day, 120 day

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Ventricle Health

Registry information

Official study title

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

Acronym: ELEVATE-HF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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