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

NCT07044700 · tracked via the Priya Life Science China tracker

Sponsor

Boehringer Ingelheim

Phase

Observational

Started

2028-01-31

Last updated

2026-09-15

Condition(s) studied

Heart Failure of Reduced Ejection Fraction (HFrEF)

Investigational drug(s) / intervention(s)

Jardiance →non-SGLT2 inhibitors

Jardiance: Jardiance

non-SGLT2 inhibitors: non-SGLT2 inhibitors

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07044700 on ClinicalTrials.gov ↗ ← All trials in China