Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure and Preserved Ejection Fraction

A Non-interventional Study of the Effectiveness and Safety Outcomes in Patients With Heart Failure and Preserved Ejection Fraction (HFpEF) Initiating Jardiance in China: A Sub-study of the Post-marketing Study of Jardiance Among Patients With Heart Failure in China

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07047508

Enrollment

3000

Registered

2025-07-02

Start date

2028-01-31

Completion date

2028-12-31

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Preserved Ejection Fraction

Brief summary

The main objective of the study is to describe the effectiveness and safety outcomes among Chinese hospitalized heart failure with preserved ejection fraction (HFpEF) patients initiating Jardiance® in the real-world setting.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years of age * At least 6 months of data prior to the index date * Left ventricular ejection fraction (LVEF) \> 40 % * N-terminal Pro-B-type natriuretic peptide (NT-proBNP) \> 125 pg/mL or brain natriuretic peptide (BNP) ≥ 35 pg/mL * At least 1 diagnosis of Heart failure with preserved ejection fraction (HFpEF) or Heart failure with mid-range ejection fraction (HFmrEF) or chronic heart failure (CHF) at baseline during the look-back period (on or prior to the index date) * New users of Jardiance® (initiating Jardiance® on or after March 1st, 2023, and without any record of Jardiance® prescription during the look-back period) * Body Mass Index (BMI) \<45 kg/m2

Exclusion criteria

-Patients treated with any other sodium-glucose cotransporter-2 inhibitors (SGLT2i) on the index date or during the look-back period

Design outcomes

Primary

Measure	Time frame	Description
Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death	up to 2.5 years	HHF=Hospitalization for Heart Failure CV=cardiovascular

Secondary

Measure	Time frame
Incidence of CV death	up to 2.5 years
Incidence of the HHF (the first HHF after the index date)	up to 2.5 years
Occurrence of death from any cause	up to 2.5 years

Contacts

CONTACTBoehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com1-800-243-0127

Outcome results