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Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection Fraction | Clinical Trials | Clareo Health

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

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

NCT07044700•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Fuwai Hospital; National Center for Cardiovascular Diseases

Beijing, China

Key Dates

Start Date

January 31, 2028

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

February 18, 2026

Enrollment

5,000

ESTIMATED participants

Conditions

Heart Failure of Reduced Ejection Fraction (HFrEF)

Interventions

Jardiance

DRUG

non-SGLT2 inhibitors

DRUG

Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com