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

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)

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: JARDIANCE®

• Study Type: Observational
• Enrollment (Actual): 676

Contacts and Locations

Study Locations

• South Korea
  • Anyang-si, Gyeonggi-do, South Korea, 14068
    • Hallym University Medical Center
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Busan, South Korea, 47392
    • Inje University Busan Paik Hospital
  • Busan, South Korea, 48108
    • Inje university Haeundae Paik Hospital
  • Busan, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Chuncheon-si, Gangwon-do, South Korea, 24289
    • Kangwon National University Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Daejeon, South Korea, 35015
    • Chungnam National University Hospital
  • Goyang-si, Gyeonggi-do, South Korea, 10326
    • dongguk University Medical Center
  • Goyang-si, Gyeonggi-do, South Korea, 10380
    • Inje University Ilsan Paik Hospital
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital)
  • Jeonju-si, Jeollabuk-do, South Korea, 54907
    • Jeonbuk National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 07061
    • Seoul National University Boramae Medical Center
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 05368
    • VHS medical center
  • Uijeongbu-si, Gyeonggi-do, South Korea, 11765
    • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with chronic heart failure (New York Heart Association (NYHA) class II-IV) in Korea.

Description

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®

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
JARDIANCE® treated patients; Patients in Korea with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus).	Drug: JARDIANCE®; JARDIANCE® film-coated tablets 10mg; Other Names: empagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Adverse Events (AEs)	Number of patients with adverse events (AEs) is reported.	Up to 407 days.
Number of Patients With Unexpected Adverse Events	Number of patients with unexpected adverse events is reported.	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.	Up to 407 days.
Number of Patients With Serious Adverse Events	Number of patients with serious adverse events is reported.	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.	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.	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.	Up to 407 days.
Number of Patients With Adverse Event of Special Interest	Number of patients with adverse event of special interest is reported.	Up to 407 days.
Number of Patients With Adverse Events Leading to Discontinuation	Number of patients with adverse events leading to discontinuation is reported.	Up to 407 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.; 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.; Worsening: If disease related factors are worse than before administration. 'Improved' and 'Unchanged' are assessed as "Effective" and 'Worsening' is assessed as "Ineffective".	Data collected at baseline (visit 1), week 12 and week 24.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; empagliflozin
• Other Study ID Numbers: 1245-0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No