Heart Failure With Reduced Ejection Fraction
Conditions
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
Interventions
OTHERDigital Heart Failure Medication Titration
Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.
Sponsors
Story Health Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in participant-reported medication adherence using the Voils score | Baseline, 6 months | The Voils score includes questions used to assess medication adherence. Answers range between not at all and very much, with 3 options in between. Not at all means a dose was not missed and Very much means dose was missed for that reason. |
| Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score | Baseline, 6 months | The Kansas City Cardiomyopathy Questionnaire 12-item version includes multiple domains: symptom frequency, quality of life, social limitation, and physical limitation. The Overall Summary score incorporates the averages of these 4 domains and is reported on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
| Global rank score across 3 hierarchical tiers of a composite outcome: time to death, time to HF hospitalization, change from baseline to last follow-up in the HF medical therapy score | baseline, 6 months | — |
| Composite of all-cause death and total worsening HF events defined by hospitalizations for acute HF and urgent HF events | 3 months, 6 months | — |
| Worsening HF events defined by hospitalizations for acute HF and urgent HF events | 3 months, 6 months | — |
| All-cause hospitalizations | 3 months, 6 months | — |
Countries
United States
Outcome results
None listed