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This study is to provide the effectiveness and safety evidence in patients with heart failure of reduced ejection fraction (HFrEF) initiating Jardiance in real clinical practice in a larger Chinese population.
The primary objective is to compare the risk of the composite outcome of cardiovascular (CV) death or hospitalisation for heart failure (HHF) in heart failure with reduced ejection fraction (HFrEF) patients initiating Jardiance with propensity score (PS) matched HFrEF patients initiating guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (SGLT2i) medications (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) in China, measured by the hazard ratio of the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients initiating Jardiance | Initiation of Jardiance for heart failure of reduced ejection fraction (HFrEF) treatment after the launch of HFrEF indication in China |
| |
| Patients initiating other non-SGLT2i medications (ACEi/ARB/ARNI, beta-blockers, and MRA) | Initiation of a different guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (non-SGLT2i) medication class (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) for HFrEF treatment, after the launch of HFrEF indication of Jardiance in China |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jardiance | Drug | Jardiance |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Time from the index date to the first hospitalisation for heart failure (HHF) or cardiovascular (CV) death | From the index date to the end date of each individual's follow-up, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time from the index date to cardiovascular (CV) death | From the index date to the end date of each individual's follow-up, up to 3 years | |
| Time from the index date to the first hospitalisation for heart failure (HHF) | From the index date to the end date of each individual's follow-up, up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients with heart failure of reduced ejection fraction (HFrEF) included by the heart failure medical union of the national center for cardiovascular diseases (HFMU-NCCD). In the database, heart failure with reduced ejection fraction (HFrEF) is defined as left ventricular ejection fraction (LVEF) <40%.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital; National Center for Cardiovascular Diseases | Beijing | 100037 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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| non-SGLT2 inhibitors | Drug | non-SGLT2 inhibitors |
|
| Total number of HHFs at 30 days after the index date | At 30 days after the index date |
| Total number of HHFs at 90 days after the index date | At 90 days after the index date |
| Total number of HHFs at 1 year after the index date | At 1 year after the index date |
| Time from the index date to all-cause death | From the index date to the end date of each individual's follow-up, up to 3 years |
| ID | Term |
|---|---|
| C570240 | empagliflozin |
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