Clinical trial NCT03387163: Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Official title: PROVIDE-HF: Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Systolic
Keywords: 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)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 adult patients with chronic systolic HF in PCORnet. We will focus on chronic systolic HF patients initiated on sacubitril/valsartan and a comparator group not initiated on sacubitril/valsartan sacubitril (but with background ACE/ARB therapy and recent titration of these medications).

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 beneficial outcomes associated with the use of this therapy.

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 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline to 12 weeks in the KCCQ
timeFrame: Baseline to weeks 2, 4, 8 and 12
Secondary outcomes:
measure: Responder analysis for a 5-point improvement in KCCQ to week 12
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Mentz RJ, Xu H, O'Brien EC, Thomas L, Alexy T, Gupta B, Vilaro J, Lala A, DeVore AD, Dhingra R, Briasoulis A, Simon MA, Stehlik J, Rodgers JE, Dunlay SM, Abshire M, Wells QS, Barringhaus KG, Eckman PM, Lowes BD, Espinoza J, Blanco R, Shen X, Duffy CI, Hernandez AF. PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure. Am Heart J. 2020 Dec;230:35-43. doi: 10.1016/j.ahj.2020.09.012. Epub 2020 Sep 24.