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The aim of this study was to describe the real-world clinical profile, treatment patterns, and guideline alignment of patients with heart failure with reduced ejection fraction (HFrEF) treated with sacubitril/valsartan in routine clinical practice in Romania. The study used secondary use of data, with all analyses conducted on anonymized, pre-existing data collected for routine clinical and administrative purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril/Valsartan Cohort | Adults with a recorded diagnosis of HFrEF and ≥1 prescription of sacubitril/valsartan during the study period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Receiving all Four Guideline-recommended Therapeutic Classes for HFrEF | The four guideline-recommended therapeutic classes include sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 (SGLT2) inhibitors. | Up to approximately 5 years and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients by Demographic Category | Demographics include age group and sex. | Up to approximately 5 years and 6 months |
| Percentage of Patients by Clinical Characteristic Category | Clinical characteristics include treating physician specialty, diagnosis, comorbidities, and concomitant medications. |
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Inclusion criteria:
Exclusion criteria:
• Patients who do not meet inclusion criteria.
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Adult patients with HFrEF and at least one prescription of sacubitril/valsartan.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Bucharest | 020334 | Romania |
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| Up to approximately 5 years and 6 months |
| Percentage of Patients Who Used Angiotensin-converting Enzyme (ACE) Inhibitors and/or Angiotensin Receptor Blockers Before Starting Sacubitril/Valsartan Treatment | Up to approximately 5 years and 6 months |
| Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation | Baseline |
| Percentage of Patients by Dosing Frequency | Up to approximately 5 years and 6 months |
| Duration of Sacubitril/Valsartan Treatment | Up to approximately 5 years and 6 months |
| Percentage of Patients by Use of Individual Guideline-recommended Pharmacological Therapeutic Classes for HFrEF | Guideline-recommended pharmacological therapeutic classes for HFrEF include beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors. | Up to approximately 5 years and 6 months |
| Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications | Up to approximately 5 years and 6 months |
| Number of Concomitant Cardiovascular Medications | Up to approximately 5 years and 6 months |