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

Not Applicable

Terminated

• Conditions: Heart Failure
• Interventions: Device: Biobeat Wrist Watch; Other: Standard of Care

• Registration Number: NCT04292275
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Study Start: 2020-03-06
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Health Tools + Standard of Care	Standard of Care	-
Standard of Care	Standard of Care	-
Digital Health Tools + Standard of Care	Biobeat Wrist Watch	-

Primary Outcome Measures

Name	Time	Method
Time to Change or Decision That Heart Failure Therapy is Optimal	Randomization to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Time to change or decision that heart failure therapy is optimal	Baseline to 6 months	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)	Week 24	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.
Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores	Baseline and Week 24	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.
Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores	Week 24	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.
Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy	Baseline and Week 24	Participants will complete a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.

Trial Locations

Locations (8)

Cardiology Associates of Fairfield County, PC; 🇺🇸 Stamford, Connecticut, United States

Diagnostic Cardiology Group; 🇺🇸 Chattanooga, Tennessee, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

MercyOne Northeast Iowa Family Medicine and Residency; 🇺🇸 Waterloo, Iowa, United States

Inova Heart and Vascular Institute; 🇺🇸 Falls Church, Virginia, United States

Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC; 🇺🇸 Tullahoma, Tennessee, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Virtua Health Inc.; 🇺🇸 Voorhees, New Jersey, United States