Status:
COMPLETED
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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 Resear...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2019
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT03387163
Start Date
February 9 2018
End Date
June 21 2019
Last Update
December 13 2019
Active Locations (1)
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1
Novartis Investigative Site
New York, New York, United States, 10029