Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection Fraction
NCT ID: NCT07044700
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
5000 participants
OBSERVATIONAL
2026-01-31
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients initiating Jardiance
Initiation of Jardiance for heart failure of reduced ejection fraction (HFrEF) treatment after the launch of HFrEF indication in China
Jardiance
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
non-SGLT2 inhibitors
non-SGLT2 inhibitors
Interventions
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Jardiance
Jardiance
non-SGLT2 inhibitors
non-SGLT2 inhibitors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 other SGLT-2i on the index date
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Fuwai Hospital; National Center for Cardiovascular Diseases
Beijing, , China
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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1245-0291
Identifier Type: -
Identifier Source: org_study_id
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