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

Boehringer Ingelheim676 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

676

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

Number of Patients With Adverse Events (AEs)

Number of patients with adverse events (AEs) is reported.

Time frame: Up to 407 days.

Number of Patients With Unexpected Adverse Events

Number of patients with unexpected adverse events is reported.

Time frame: Up to 407 days.

Number of Patients With Unexpected Adverse Drug Reaction

Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.

Time frame: Up to 407 days.

Number of Patients With Serious Adverse Events

Number of patients with serious adverse events is reported.

Time frame: Up to 407 days.

Number of Patients With Serious Adverse Drug Reaction

Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.

Time frame: Up to 407 days.

Number of Patients With Drug-related Adverse Events

Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.

Time frame: Up to 407 days.

Number of Patients With Non-serious Adverse Drug Reaction

Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.

Time frame: Up to 407 days.

Number of Patients With Adverse Event of Special Interest

Number of patients with adverse event of special interest is reported.

Data from ClinicalTrials.gov

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Secondary Outcomes

Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline

Occurrence of hospitalisation for heart failure (first and recurrent) after 12 weeks and 24 weeks of treatment from baseline was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment

Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported.

Time frame: Data collected at week 12 and week 24.

Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment

Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatment was reported. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 12 will also be presented.

Time frame: At baseline and at week 12.

Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment

Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatment was reported. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 24 will also be presented.

Time frame: At baseline and at week 24.

Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline

Changes in Ejection Fraction (EF) at 12 weeks and 24 weeks compared to baseline was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Changes in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at 12 Weeks and 24 Weeks Compared to Baseline

Changes in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at 12 weeks and 24 weeks compared to baseline was reported. The results are presented after natural log transformation.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment

Changes in Glycosylated Hemoglobin (HbA1c) after 12 weeks and 24 weeks of treatment was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks and 24 Weeks of Treatment

Change from baseline in Estimated Glomerular Filtration Rate (eGFR) after 12 weeks and 24 weeks of treatment was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Change From Baseline in Body Weight After 12 Weeks and 24 Weeks of Treatment

Change from baseline in Body weight after 12 weeks and 24 weeks of treatment was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Change From Baseline in Systolic Blood Pressure (SBP) After 12 Weeks and 24 Weeks of Treatment

Change from baseline in Systolic Blood Pressure (SBP) after 12 weeks and 24 weeks of treatment was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

Change From Baseline in Diastolic Blood Pressure (DBP) After 12 Weeks and 24 Weeks of Treatment

Change from baseline in Diastolic Blood Pressure (DBP) after 12 weeks and 24 weeks of treatment was reported.

Time frame: Data collected at baseline (visit 1), week 12 and week 24.

The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment

The result of investigator's overall evaluation at the final visit was reported. The final visit represents each patient's last assessment among Week 12 or Week 24. For the final effectiveness evaluation, the three items (Improved, Unchanged, Worsening) are evaluated by the changes from baseline of the NYHA Class at the end of last visit. 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. Worsening: If disease related factors are worse than before administration. 'Improved' and 'Unchanged' are assessed as "Effective" and 'Worsening' is assessed as "Ineffective".

Time frame: Data collected at baseline (visit 1), week 12 and week 24.