Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection Fraction

NCT07044700 — Not yet recruiting, 5000 participants, Boehringer Ingelheim

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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

Registry	NCT07044700
Status	Not yet recruiting
Study type	Observational
Enrollment	5000 (Estimated)
Sponsor	Boehringer Ingelheim (Industry)
Conditions	Heart Failure of Reduced Ejection Fraction (HFrEF)
Interventions	Jardiance, non-SGLT2 inhibitors (Drug)
Dates	start 2028-01-31 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2025-07-01, last updated 2026-09-15
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients initiating Jardiance		Drug: 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)		Drug: non-SGLT2 inhibitors	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

Jardiance (Drug), also known as Empagliflozin: Jardiance
non-SGLT2 inhibitors (Drug): non-SGLT2 inhibitors

+Outcome measures

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]
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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Fuwai Hospital; National Center for Cardiovascular Diseases	Beijing	China