Non-interventional Study of the Effectiveness and Safety of Jardiance in Patients With Heart Failure (HF) of Reduced Ejection Fraction (HFrEF) Compared to Guideline-recommended Non-SGLT2i Therapy Regimens in China: A Sub-study of the Postmarketing Study of Jardiance Among Patients With Heart Failure in China

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 5,000 participants

Study Arms

• 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

Interventions

• DRUG: Jardiance — Jardiance
• DRUG: non-SGLT2 inhibitors — non-SGLT2 inhibitors

Primary Outcomes

• 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 Outcomes

• 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)

Eligibility Criteria

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

Trial Locations

• Fuwai Hospital; National Center for Cardiovascular Diseases, Beijing, China

Contact Information

• Boehringer Ingelheim — CONTACT
  Phone: 1-800-243-0127
  Email: clintriage.rdg@boehringer-ingelheim.com

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