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| Name | Class |
|---|---|
| Story Health Inc. | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Heart Failure Medication Titration | Experimental | 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. |
|
| Usual Care | No Intervention | Routine clinical care will be followed. Participants will also receive a blood pressure cuff and scale, though the data will not be routinely fed back to the treating clinicians unless requested. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Heart Failure Medication Titration | Other | Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medical therapy, as measured by the Heart Failure Medical Therapy Score | 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 | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medical therapy, as measured by the Kansas City Medical Optimization score | Scores are the average of the total daily dose to target dose values for HF medications. Scores range from 0-100. | Baseline, 6 months |
| Intensification of evidence-based medical therapies, measured by number of participants with reported changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant-reported medication adherence using the Voils score | 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. | Baseline, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam DeVore, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | 32405 | United States | ||
| Ascension St. Vincent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40473009 | Derived | Khan MS, Sauer AJ, Green CL, McDermott J, Khan MS, Chaudhry SP, Haghighat AR, Bennett MK, Martyn T, Shah H, Govil A, Stanis T, Albert NM, DeVore AD. Rationale, design, and baseline characteristics of the virtual care to improve heart failure outcomes (VITAL-HF) trial. Am Heart J. 2025 Dec;290:46-57. doi: 10.1016/j.ahj.2025.06.001. Epub 2025 Jun 3. |
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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. |
| baseline, 6 months |
| Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up. | The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines. | 6 months |
| Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up. | The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines. | 6 months |
| Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence | Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema | 3 months, 6 months |
| Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score |
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. |
| Baseline, 6 months |
| 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 |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Saint Luke's Health Systems | Kansas City | Missouri | 64111 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |