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

Heart Failure, Systolic Clinical Trial

— PROVIDE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387163
• Other study ID #: CLCZ696BUS17
• Status: Completed
• Start date: February 9, 2018
• Est. completion date: June 21, 2019

Study information

• Verified date: December 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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