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

Boehringer Ingelheim

Status: Not yet enrolling

Conditions: Preserved Ejection Fraction; Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT07047508

1245-0313

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

3,000 participants in 1 patient group

Heart failure and preserved ejection fraction patients