Status:
TERMINATED
Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring
Lead Sponsor:
Amgen
Conditions:
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04292275
Start Date
March 6 2020
End Date
October 1 2021
Last Update
August 8 2023
Active Locations (8)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
2
Cardiology Associates of Fairfield County, PC
Stamford, Connecticut, United States, 06905
3
MercyOne Northeast Iowa Family Medicine and Residency
Waterloo, Iowa, United States, 50702
4
Virtua Health Inc.
Voorhees Township, New Jersey, United States, 08043