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This was a non-interventional retrospective cohort study of de novo heart failure with reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment on either sacubitril/valsartan or commencing or continuing angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blocker (ARB) therapy for HF in the United States (US) using the secondary source of data, Optum Electronic Health Records (EHR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril/valsartan | Prescribed sacubitril/valsartan | ||
| ACEi/ARB | Prescribed ACEi or ARB |
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| Measure | Description | Time Frame |
|---|---|---|
| Total number of all-cause hospitalizations | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first all-cause hospitalization | Up to approximately 5 years | |
| Number and proportion of HF-specific inpatient hospitalizations | Up to approximately 5 years | |
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Inclusion Criteria:
Sacubitril/valsartan cohort:
ACEi/ARB cohort:
Exclusion Criteria
Sacubitril/valsartan cohort:
ACEi/ARB cohort:
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| Number and proportion of HF-related inpatient hospitalizations |
| Up to approximately 5 years |
| Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations | Up to approximately 5 years |
| Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations | Up to approximately 5 years |
| Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations. | Up to approximately 5 years |
| Number and proportion of patients with ≥1 implantable cardioverter defibrillator (ICD) insertion during a hospitalization or during an emergency room (ER) visit for both the sacubitril/valsartan and ACEi/ARB cohorts | Up to approximately 5 years |
| Number and proportion of non-HF inpatient hospitalizations | Up to approximately 5 years |
| Number and proportion of non-CV inpatient hospitalizations | Up to approximately 5 years |
| Dosages and dose changes of sacubitril/valsartan administered | Up to approximately 5 years |