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

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Amgen
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Updated on 16 February 2024
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ejection fraction
chronic heart failure

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.

Details
Condition Heart failure, Heart failure, Heart disease, Heart disease
Age 18years - 85years
Treatment Standard of Care, Biobeat Wrist Watch
Clinical Study IdentifierNCT04292275
SponsorAmgen
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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