Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Other: Digital Heart Failure Medication Titration
- Registration Number
- NCT05602454
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 178
- Age >18 years of age
- Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year prior to screening. Any validated method for assessing LVEF may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. For participants with an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an LVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. The enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset HFrEF.
- Access to a smartphone including through a family member of caregiver
- Fluent in written and spoken English
- Optimized or nearly-optimized on evidence-based medical therapies for HFrEF 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 or ongoing chronic dialysis at screening
- Prior heart transplant
- Current or planned left ventricular assist device
- Currently receiving hospice care
- Chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel
- Terminal illness other than HF with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Digital Heart Failure Medication Titration Digital Heart Failure Medication Titration The Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc.
- Primary Outcome Measures
Name Time Method Change in medical therapy, as measured by the Heart Failure Medical Therapy Score Baseline, 6 months Scores are 0-3 for 7 key medication classes for heart failure with reduced ejection fraction where 0 represents no use of the medication class
- Secondary Outcome Measures
Name Time Method Intensification of evidence-based medical therapies, measured by number of participants with reported changes. baseline, 6 months Proportion of participants with any intensification of and cumulative number of intensifications of evidence-based medical therapies for HFrEF from baseline to last follow-up.
Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up. 6 months The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence 3 months, 6 months Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema
Change in medical therapy, as measured by the Kansas City Medical Optimization score Baseline, 6 months Scores are the average of the total daily dose to target dose values for HF medications. Scores range from 0-100.
Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up. 6 months The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.
Trial Locations
- Locations (7)
Cardiovascular Institute of Northwest Florida
🇺🇸Panama City, Florida, United States
Ascension St. Vincent
🇺🇸Indianapolis, Indiana, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Saint Luke's Health Systems
🇺🇸Kansas City, Missouri, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States