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

NCT ID: NCT06592508

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-27
• Study Completion Date: 2026-02-10

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 quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.

Conditions

Heart Failure; With Decompensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote Virtual Cardiology Program

Intervention Type: 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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ventricle Health

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam DeVore

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Duke Raleigh Hospital

Raleigh, North Carolina, United States

Premier Health

Dayton, Ohio, United States

ProMedica Toledo Hospital

Toledo, Ohio, United States

Countries

United States

Other Identifiers

Pro00115672

Identifier Type: -

Identifier Source: org_study_id