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Behavioural Intervention

Virtual Cardiology Program for Heart Failure (ELEVATE-HF Trial)

N/A

Recruiting

Led By Adam DeVore

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years of age

Be older than 18 years old

Must not have

History of prior heart transplant or currently listed for heart transplant

Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 day, 60 day, 120 day

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a virtual cardiology program that educates patients on heart failure, monitors their condition, and adjusts medications quickly is better than the usual care for patients recently hospitalized with heart failure

Who is the study for?

This trial is for patients recently hospitalized with acute decompensated heart failure. It's designed to help those who could benefit from a virtual cardiology program that educates and monitors them, adjusting their medications as needed.

What is being tested?

The study tests the safety and effectiveness of a remote virtual cardiology program against standard care. The program provides education, monitors symptoms, and adjusts heart failure medications remotely.

What are the potential side effects?

Since this trial involves educational and monitoring components rather than drugs or invasive procedures, side effects are minimal but may include privacy concerns or stress related to technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart transplant or am on the waiting list for one.

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I regularly use IV medications like milrinone, dobutamine, or dopamine.

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My kidney function is very low or I am on long-term dialysis.

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I am currently in hospice care.

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My doctor does not expect me to live more than a year due to an illness other than heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 day, 60 day, 120 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 day, 60 day, 120 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 day, 60 day, 120 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Number of participants with combined Emergency department visits and hospitalizations

Other study objectives

Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score

Change in participant-reported medication adherence using the Voils score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: Remote Virtual Cardiology ProgramExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site.

0 / 6Eligibility criteria met