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): 610

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
    • Hallym University Medical Center
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Chuncheon-si, Gangwon-do, Korea, Republic of, 24289
    • Kangwon National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam national university hospital
  • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
    • Dongguk University Medical Center
  • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
    • Inje University Ilsan Paik Hospital
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital)
  • Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
    • Jeonbuk National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of, 05368
    • VHS Medical Center
  • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 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
Patients who have started at first time on Jardiance®	Drug: JARDIANCE®; JARDIANCE® film-coated tablets 10mg; Other Names: empagliflozin

What is the study measuring?

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

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): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

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