Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure (PROVIDE-HF)

Novartis

Status: Completed

Conditions: Heart Failure, Systolic

Treatments: Drug: Sacubitril/Valsartan

Study type: Observational

Funder types: Industry

Identifiers

NCT03387163

CLCZ696BUS17

Details and patient eligibility

About

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.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

402 participants in 2 patient groups

Sacubitril/Valsartan

Description:

Chronic systolic heart failure patients newly prescribed in mg. twice daily.

Treatment:

Drug: Sacubitril/Valsartan

ACEi/ARB

Description:

Chronic systolic heart failure patients receiving ACEi/ARB and no s/v