A regulatory requirement non-interventional study to monitor the safety and effectiveness of Jardiance® (empagliflozin, 10mg) in Korean patients with chronic heart failure (NYHA class II-IV)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  JARDIANCE 10 MG - FILM-COATED TABLET
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK03) empagliflozin

  empagliflozin
• Medical condition to be studied:
  Cardiac failure chronic

Population studied

• Short description of the study population:
  Korean adult patients with chronic heart failure (NYHA class II-IV)
• 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:
  600

Study design details

• Study design:
  Observational prospective, single arm, non-interventional, open-label, multi-centre study;
• Main study objective:
  To monitor the safety profile and effectiveness of JARDIANCE® in Korean patients with chronic heart failure (NYHA class II-IV)
• Setting:
  1. Selection criteria; 1-1. Inclusion; - Patients who have started at first time on Jardiance® in accordance with the approved label in Korea; - Chronic heart failure (NYHA class II-IV); - Age ≥19 years at enrolment ; - Patients who have signed on the data release consent form; 1-2. Exclusion criteria:; - Patients with previous exposure to Jardiance®; - Known allergy or Hypersensitivity to active ingredients empagliflozin or to any of the excipients; - Patients with type 1 diabetes or with prior history of diabetic ketoacidosis (DKA) ; - Patient with renal impairment with eGFR < 20 mL/min/1.73 m2; - Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption; - Patient who are pregnant or are nursing or who plan to become pregnant while in the trial; - Patients for whom empagliflozin is contraindicated according local label of Jardiance;
• Comparators:
  Not applicable
• Outcomes:
  The primary objective of this study is to monitor the safety profile and effectiveness of JARDIANCE® in Korean patients with chronic heart failure (NYHA class II-IV) in a routine clinical setting. The secondary objective of this study is to monitor the occurrence of hospitalization for heart failure(first and recurrent) or cardiovascular death within 12 weeks and/or 24 weeks from baseline.
• Data analysis plan:
  1) Analysis of demographic data: Demographic data and the health status of subjects for the safety evaluation will be analysed descriptively. For continuous data, the number of patients, mean, standard deviation, minimum value, maximum value, and median will be described, while for categorical data, frequency will be shown. ; 2) Safety analysis: In the safety assessment population, the number of subjects to whom AE occurred and the number of AEs will be calculated. Also, the incidence proportion of AEs will be estimated with its 95% confidence interval. ; 3) Effectiveness analysis: Mean, standard deviation, minimum value, maximum value, and median of changes in HbA1 or FPG (if available), eGFR (if available), Body weight, and blood pressure, which were measured at the last visit versus baseline, should be presented, and analyzed using paired t-test.