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-arketing study of Jardiance among patients with heart failure in China

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single-arm

Study drug and medical condition

• Name of medicine:
  JARDIANCE

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The effectiveness and safety outcomes among Chinese hospitalized HFpEF patients initiating Jardiance in the real-world setting will be described to complement the evidence from the EMPEROR-Preserved trial. Primary Objective: To describe the incidence of composite outcome of cardiovascular (CV) death or hospitalization for heart failure (HHF) in HFpEF patients initiating Jardiance in China.
• Outcomes:
  Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death, Incidence of CV death -Incidence of the HHF (the first HHF after the index date) -Death from any cause
• Data analysis plan:
  Baseline characteristics of the HFpEF patients as listed in the section “covariates” will be described among patients who initiate Jardiance in the HFMU-NCCD data. To evaluate the difference of baseline characteristics between the RCT and this study, patients’ baseline characteristics in this study will be compared against East Asia and China patients in the treatment (Jardiance) and placebo group in the EMPEROR-Preserved trial (1245.110). The primary analysis will be an as-treated analysis. For all the study outcomes, the incidence rate and 95% confidence intervals will be calculated. The sensitivity analysis will be done which restricts to patients in regions that are well covered by the CDC mortality surveillance, to investigate the influence of mortality surveillance data quality on the results.