Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2019 |
| Start Date: | March 5, 2018 |
| End Date: | July 1, 2019 |
| Contact: | Novartis Pharmaceuticals |
| Email: | novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
PROVIDE-HF: Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
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.
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.
This is a prospective cohort study of 1500 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=750) as well as
a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=750) 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.
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=750) as well as
a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=750) 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.
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 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
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