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

Boehringer Ingelheim610 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

610

Conditions

Heart Failure

Interventions

JARDIANCE®DRUG

JARDIANCE® film-coated tablets 10mg

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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®

Locations (21)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: up to 24 weeks

Secondary Outcomes

Occurrence of hospitalization for heart failure (first and recurrent) after 12 weeks of treatment from baseline

Time frame: at week 12

Occurrence of hospitalization for heart failure (first and recurrent) after 24 weeks of treatment from baseline

Time frame: at week 24

Occurrence of cardiovascular death after 12 weeks of treatment

Time frame: at week 12

Occurrence of cardiovascular death after 24 weeks of treatment

Time frame: at week 24

Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatments

Time frame: at baseline, at week 12

Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatments

Time frame: at baseline, at week 24

Changes in ejection fraction (EF) (if available) at 12 weeks compared to baseline

Time frame: at baseline, at week 12

Changes in ejection fraction (EF) (if available) at 24 weeks compared to baseline

Data from ClinicalTrials.gov

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Inje University Busan Paik Hospital

Inje University Haeundae Paik Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Pusan National University Yangsan Hospital

Busan, South Korea

Kangwon National University Hospital

Chuncheon-si, Gangwon-do, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, South Korea

...and 11 more locations

Time frame: 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

Time frame: 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

Time frame: at baseline, at week 24

Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment

Time frame: at baseline, at week 12

Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment

Time frame: at baseline, at week 12

Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment

Time frame: at baseline, at week 24

Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment

Time frame: at baseline, at week 24

Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 12 weeks of treatment

Time frame: at baseline, at week 12

Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 24 weeks of treatment

Time frame: at baseline, at week 24

Change from baseline in body weight after 12 weeks of treatment

Time frame: at baseline, at week 12

Change from baseline in body weight after 24 weeks of treatment

Time frame: at baseline, at week 24

Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 12 weeks of treatment

Time frame: at baseline, at week 12

Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 24 weeks of treatment

Time frame: at baseline, at week 24

Investigator's overall effectiveness evaluation after 12 weeks of treatment

1. Improved: If determined as there is any effect of maintaining or improving disease related factors. 2. Unchanged: If disease related factors have not been changed compared with before administration, and not determined as there is any effect of maintaining symptoms. 3. Aggravated: If disease related factors are worse than before administration. 4. 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".

Time frame: at week 12

Investigator's overall effectiveness evaluation after 24 weeks of treatment

Time frame: at week 24