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

Amgen

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Biobeat Wrist Watch; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04292275

20180096

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Digital Health Tools + Standard of Care

Experimental group

Treatment:

Device: Biobeat Wrist Watch

Other: Standard of Care

Standard of Care

Other group

Treatment:

Other: Standard of Care