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

NCT ID: NCT03387163

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-09

Study Completion Date

2019-06-21

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.

Conditions

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Heart Failure, Systolic

Keywords

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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)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Sacubitril/Valsartan

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

Sacubitril/Valsartan

Intervention Type DRUG

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

ACEi/ARB

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

No interventions assigned to this group

Interventions

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Sacubitril/Valsartan

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32980364 (View on PubMed)

Other Identifiers

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CLCZ696BUS17

Identifier Type: -

Identifier Source: org_study_id