NCT03387163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

December 21, 2017

Last Update Submit

December 11, 2019

Conditions

Heart Failure, Systolic

Keywords

Heart failureReduced left ventricular ejection fractionChronic Systolic Heart failureSacubitril /ValsartanPatient reported outcomes (PRO)Kansas City Cardiomyopathy Questionnaire (KCCQ)Patient Centered Outcomes Research Network (PCORNeT)Common Data Model (CDM)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Baseline to week 12

Study Arms (2)

Sacubitril/Valsartan

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

Drug: Sacubitril/Valsartan

ACEi/ARB

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

Interventions

Sacubitril/ValsartanDRUG

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

Sacubitril/Valsartan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide informed consent
  • Life expectancy \< 6 months
  • For comparator group patients: Physician documentation of planned initiation of sacubitril/valsartan within 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 32980364DERIVED

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 29, 2017

Study Start

February 9, 2018

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

US(1)