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

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

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

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.

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.

Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.

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.

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.

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.

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.

Participants will complete a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.

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.

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.

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.