PROVIDE-HF: Patient Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (Sacubitril/Valsartan) in Heart Failure

Age: 18 - 45 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: June 17, 2017

End Date: August 20, 2017

Contact Information:

This is a prospective cohort study of 1500 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=750) as well as a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=750) 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.


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 ePRO forms)

- Newly initiating sacubitril/valsartan (observational treatment group only – within 1 week of first dose)

- At least a 25% change ACE/ARB dose 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