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| Name | Class |
|---|---|
| Ventricle Health | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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, 120 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam DeVore | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | 32405 | United States | ||
| Northeast Georgia Medical Center |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline, 120 days |
| Change in the number of classes of HF (heart failure) medications | by different HF classifications as defined by LVEF | 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 | Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HF including symptomatic hypotension, hyperkalemia, and angioedema. | 30 day, 60 day, 120 day |
| 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, 120 day |
| Net promoter score as assessed by the Ventricle Health Performance Survey | 120 day |
| Number of participants with All-cause hospitalization | 30 day, 60 day, 120 day |
| Gainesville |
| Georgia |
| 30501 |
| United States |
| Duke Raleigh Hospital | Raleigh | North Carolina | 27609 | United States |
| Premier Health | Dayton | Ohio | 45409 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43615 | United States |