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Not Yet RecruitingNCT07044700

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
5,000 (estimated)
Sponsor
Boehringer Ingelheim · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGJardianceJardiance
DRUGnon-SGLT2 inhibitorsnon-SGLT2 inhibitors

Timeline

Start date
2028-01-31
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2025-07-01
Last updated
2026-02-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07044700. Inclusion in this directory is not an endorsement.