Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure and Preserved Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Preserved Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death [Time frame: up to 2.5 years]
Secondary outcome measures (3)
- Incidence of CV death [Time frame: up to 2.5 years]
- Incidence of the HHF (the first HHF after the index date) [Time frame: up to 2.5 years]
- Occurrence of death from any cause [Time frame: up to 2.5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07047508 · 1245-0313