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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure, Systolic

Intervention / Treatment
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* Drug: Sacubitril/Valsartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sacubitril/Valsartan<br>Chronic systolic heart failure patients newly prescribed in mg. twice daily. | Drug: Sacubitril/Valsartan<br>* commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103<br>|
| ACEi/ARB<br>Chronic systolic heart failure patients receiving ACEi/ARB and no s/v | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to weeks 2, 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder analysis for a 5-point improvement in KCCQ to week 12 | Binary response for a 5-point improvement in KCCQ to week 12 | Baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Reduced left ventricular ejection fraction, Chronic Systolic Heart failure, Sacubitril /Valsartan, Patient reported outcomes (PRO), Kansas City Cardiomyopathy Questionnaire (KCCQ), Patient Centered Outcomes Research Network (PCORNeT), Common Data Model (CDM)