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

NCT07044700 | Not Yet Recruiting

• 1 other identifier: 1245-0291
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure of Reduced Ejection Fraction (HFrEF)

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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

Study Arms (2)

Patients initiating Jardiance

Initiation of Jardiance for heart failure of reduced ejection fraction (HFrEF) treatment after the launch of HFrEF indication in China

Drug: Jardiance

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

Drug: non-SGLT2 inhibitors

Interventions

Jardiance DRUG

Jardiance

Also known as: Empagliflozin

Patients initiating Jardiance

non-SGLT2 inhibitors DRUG

non-SGLT2 inhibitors

Patients initiating other non-SGLT2i medications (ACEi/ARB/ARNI, beta-blockers, and MRA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with heart failure of reduced ejection fraction (HFrEF) included by the heart failure medical union of the national center for cardiovascular diseases (HFMU-NCCD). In the database, heart failure with reduced ejection fraction (HFrEF) is defined as left ventricular ejection fraction (LVEF) \<40%.

You may qualify if:

• 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

You may not qualify if:

• Patients treated with any SGLT-2i during the look-back period
• Patients treated with any other SGLT-2i on the index date

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Fuwai Hospital; National Center for Cardiovascular Diseases

Beijing, 100037, China

Location

Related Links

• Related Info

MeSH Terms

Interventions

empagliflozin

Central Study Contacts

Boehringer Ingelheim

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 1, 2025
• Study Start (Estimated): January 31, 2028
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)