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

Completed

Conditions studied: Heart Failure, Systolic

In brief

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.

Key facts

Study ID

NCT03387163

Run by

Novartis Pharmaceuticals

People needed

402

Starts

2018-02-09

Expected to finish

2019-06-21

Last updated by the study team

2019-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — New York, New York, United States

Full record on ClinicalTrials.gov

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