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

Completed

• Conditions: Heart Failure, Systolic
• Interventions: Drug: Sacubitril/Valsartan

• Registration Number: NCT03387163
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-02-09
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sacubitril/Valsartan	Sacubitril/Valsartan	Chronic systolic heart failure patients newly prescribed in mg. twice daily.

Primary Outcome Measures

Name	Time	Method
Change from baseline to 12 weeks in the KCCQ	Baseline to weeks 2, 4, 8 and 12	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.

Secondary Outcome Measures

Name	Time	Method
Responder analysis for a 5-point improvement in KCCQ to week 12	Baseline to week 12	Binary response for a 5-point improvement in KCCQ to week 12

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 New York, New York, United States