Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring

Study Overview
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Brief Summary
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A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.

Official Title
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A Randomized, Open-Label, Standard-of-Care-Controlled, Multicenter Study to Evaluate Digital Health Data Use in Managing Guideline-Directed Heart Failure Therapy

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Biobeat Wrist Watch
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of chronic heart failure. Ejection fraction equal to or below 40%. New York Heart Association (NYHA) class II to class III. Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure. Exclusion Criteria: Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney). Currently in an investigational device or drug study. Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Health Tools + Standard of Care<br> | Device: Biobeat Wrist Watch<br>* Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.<br>Other: Standard of Care<br>* Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.<br>|
| Other: Standard of Care<br> | Other: Standard of Care<br>* Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Change or Decision That Heart Failure Therapy is Optimal | Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy. | Randomization to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to change or decision that heart failure therapy is optimal | Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy, time to change or decision that dose is optimal. | Baseline to 6 months | 
| Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP) | Health-ITUES-HCP will be used to assess the healthcare provider's experience with the digital health tool(s) and data presentation. The scale consists of 36 items. A higher score indicated higher perceived usability of the technology. | Week 24 | 
| Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores | Health-ITUES-Subject will be used to assess the participant's experience with the digital health tool(s). The scale consists of 36 items. A higher score indicated higher perceived usability of the technology. | Week 24 | 
| Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy | Participants will complete a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied. | Baseline and Week 24 | 
| Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores | The KCCQ-23 is a 23-item questionnaire to measure the participant's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. All items are measured on a Likert scale with 5-7 response options. Scores for each item are standardized to range from 0 to 100 with higher scores indicating better health status, fewer symptoms, and greater disease-specific health-related quality of life. | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital health, Remote monitoring, Wearable device