Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure
Not Applicable
Recruiting
- Conditions
- Heart Failure; With Decompensation
- Interventions
- Other: Remote Virtual Cardiology Program
- Registration Number
- NCT06592508
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Remote Virtual Cardiology Program 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 by different HF classifications as defined by LVEF
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 Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HF including symptomatic hypotension, hyperkalemia, and angioedema.
Trial Locations
- Locations (2)
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Duke Raleigh Hospital
🇺🇸Raleigh, North Carolina, United States