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

Not yet recruiting

• Conditions: Heart Failure of Reduced Ejection Fraction (HFrEF)

• Registration Number: NCT07044700
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study Start: 2025-06-30
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Total number of HHFs at 1 year after the index date	At 1 year after the index date
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
Time from the index date to all-cause death	From the index date to the end date of each individual's follow-up, up to 3 years

Trial Locations

Locations (1)

Fuwai Hospital; National Center for Cardiovascular Diseases; 🇨🇳 Beijing, China