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

Novartis Pharmaceuticals402 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

402

Conditions

Heart Failure, Systolic

Interventions

Sacubitril/ValsartanDRUG

commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

New York, New York, United States

Outcomes

Primary Outcomes

Change from baseline to 12 weeks in the KCCQ

Kansas City Cardiomyopathy Questionnaire (KCCQ) - self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life in patients with heart failure.

Time frame: Baseline to weeks 2, 4, 8 and 12

Secondary Outcomes

Responder analysis for a 5-point improvement in KCCQ to week 12

Binary response for a 5-point improvement in KCCQ to week 12

Time frame: Baseline to week 12

Data from ClinicalTrials.gov

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