Heart Failure of Reduced Ejection Fraction (HFrEF)
Conditions
Brief summary
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.
Interventions
DRUGJardiance
Jardiance
DRUGnon-SGLT2 inhibitors
non-SGLT2 inhibitors
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Has at least 1 diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) at baseline during the 6-month look-back period (on or prior to the index date) * Left Ventricular Ejection Fraction (LVEF) ≤40% * N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) \>125pg/mL or Brain Natriuretic Peptide (BNP)≥35 pg/mL * New users of Jardiance or 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), beta-blockers, and Mineralocorticoid Receptor Antagonist (MRA)) for HFrEF, who had not used the respective index drug during the look-back period * Baseline data during the look-back period or on the index date have been collected * Body mass index (BMI) \<45 kg/m2
Exclusion criteria
* Patients treated with any SGLT-2i during the look-back period * Patients treated with any other SGLT-2i on the index date
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
China
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed