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

Heart Failure Clinical Trial

— HF-eVOLUTION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04292275
• Other study ID #: 20180096
• Status: Terminated
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: August 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Biobeat Wrist Watch
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.

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

Locations

Country	Name	City	State
United States	Diagnostic Cardiology Group	Chattanooga	Tennessee
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Cardiology Associates of Fairfield County, PC	Stamford	Connecticut
United States	Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC	Tullahoma	Tennessee
United States	Virtua Health Inc.	Voorhees	New Jersey
United States	MercyOne Northeast Iowa Family Medicine and Residency	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   AmgenTrials clinical trials website