Heart Failure Clinical Trial
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Summary
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.
Full Description
This is a prospective cohort study of 400 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify a cohort of chronic systolic HF patients initiated on sacubitril/valsartan (N=200) as well as a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=200) but with background ACE/ARB therapy and (2) evaluate baseline and follow-up PROs via an electronic patient reported outcomes (ePRO) form in the eCOS database for 12 weeks.
Eligibility Criteria
Inclusion Criteria
Diagnosis of chronic systolic HF
Active care by a provider in a healthcare system connected to a PCORnet data partner
Ability to speak and read English (given the use of the English ePRO technology)
Newly initiating sacubitril/valsartan (observational sacubitril/valsartan treatment group only - within 1 week of first dose)
At least a 25% change ACE/ARB dose (including increase and decrease; or initiation or medication switching to another ACEI/ARB) in the last 6 months (comparator group only)
Reliable access to the internet
Exclusion criteria:
Inability to provide informed consent
Life expectancy < 6 months
For comparator group patients: Physician documentation of planned initiation of sacubitril/valsartan within 12 weeks
Other protocol inclusion/exclusion criteria may apply
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There is 1 Location for this study
New York New York, 10029, United States
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