Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.

Official Title
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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)

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: JARDIANCE®


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients who have started at first time on Jardiance® in accordance with the approved label in Korea for heart failure (HF) Chronic heart failure (New York Heart Association (NYHA) class II-IV) Age ≥ 19 years at enrolment Patients who have signed on the data release consent form 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 estimated Glomerular Filtration Rate (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®

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who have started at first time on Jardiance®<br> | Drug: JARDIANCE®<br>* JARDIANCE® film-coated tablets 10mg<br>* Other names: empagliflozin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of patients with adverse events | Adverse events will include: Adverse events, unexpected adverse events, unexpected adverse drug reaction, serious adverse events, serious adverse drug reaction, drug-related adverse events, non-serious adverse drug reaction, adverse event of special interest, adverse events leading to discontinuation. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hospitalization for heart failure (first and recurrent) after 12 weeks of treatment from baseline |  | at week 12 | 
| Occurrence of hospitalization for heart failure (first and recurrent) after 24 weeks of treatment from baseline |  | at week 24 | 
| Occurrence of cardiovascular death after 12 weeks of treatment |  | at week 12 | 
| Occurrence of cardiovascular death after 24 weeks of treatment |  | at week 24 | 
| Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatments |  | at baseline, at week 12 | 
| Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatments |  | at baseline, at week 24 | 
| Changes in ejection fraction (EF) (if available) at 12 weeks compared to baseline |  | at baseline, at week 12 | 
| Changes in ejection fraction (EF) (if available) at 24 weeks compared to baseline |  | at baseline, at week 24 | 
| Changes in B-type Natriuretic Peptide (BNP) or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (if available) at 12 weeks compared to baseline |  | at baseline, at week 12 | 
| Changes in B-type Natriuretic Peptide (BNP) or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (if available) at 24 weeks compared to baseline |  | at baseline, at week 24 | 
| Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment |  | at baseline, at week 12 | 
| Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment |  | at baseline, at week 12 | 
| Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment |  | at baseline, at week 24 | 
| Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment |  | at baseline, at week 24 | 
| Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 24 weeks of treatment |  | at baseline, at week 24 | 
| Change from baseline in body weight after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in body weight after 24 weeks of treatment |  | at baseline, at week 24 | 
| Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 24 weeks of treatment |  | at baseline, at week 24 | 
| Investigator's overall effectiveness evaluation after 12 weeks of treatment | Improved: If determined as there is any effect of maintaining or improving disease related factors. Unchanged: If disease related factors have not been changed compared with before administration, and not determined as there is any effect of maintaining symptoms. Aggravated: If disease related factors are worse than before administration. Unassessable: If it cannot be determined due to insufficient information collected. (Even though there are any objective indicators present, it is possible to belong to this grade.) 'Improved' is assessed as Effective, 'Unchanged' and 'Aggravated' are assessed as Ineffective. | at week 12 | 
| Investigator's overall effectiveness evaluation after 24 weeks of treatment | Improved: If determined as there is any effect of maintaining or improving disease related factors. Unchanged: If disease related factors have not been changed compared with before administration, and not determined as there is any effect of maintaining symptoms. Aggravated: If disease related factors are worse than before administration. Unassessable: If it cannot be determined due to insufficient information collected. (Even though there are any objective indicators present, it is possible to belong to this grade.) 'Improved' is assessed as Effective, 'Unchanged' and 'Aggravated' are assessed as Ineffective. | at week 24 |