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

NCT06592508 | Active Not Recruiting

• 1 other identifier: Pro00115672
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

  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

  30 day, 60 day, 120 day

Other Outcomes (4)

• Change in participant-reported medication adherence using the Voils score

  Baseline, 120 day

• Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score

  Baseline, 120 day

• Net promoter score as assessed by the Ventricle Health Performance Survey

  120 day

Study Arms (2)

Experimental: Remote Virtual Cardiology Program

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

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.

Experimental: Remote Virtual Cardiology Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Ventricle Health: collaborator

Study Sites (5)

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32405, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

Premier Health

Dayton, Ohio, 45409, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43615, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Adam DeVore

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 27, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)