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Completed

NCT Number: NCT05236673

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Medical Center, Anyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

JARDIANCE®

Drug

JARDIANCE® film-coated tablets 10mg

Other names: empagliflozin

Primary outcomes

  1. Incidence rates of patients with adverse events

    Time frame: up to 24 weeks

    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.

Secondary outcomes

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

    Time frame: at week 12

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

    Time frame: at week 24

  3. Occurrence of cardiovascular death after 12 weeks of treatment

    Time frame: at week 12

  4. Occurrence of cardiovascular death after 24 weeks of treatment

    Time frame: at week 24

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

    Time frame: at baseline, at week 12

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

    Time frame: at baseline, at week 24

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

    Time frame: at baseline, at week 12

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

    Time frame: at baseline, at week 24

  9. 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

  10. 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

  11. 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

  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

  13. 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

  14. 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

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

    Time frame: at baseline, at week 12

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

    Time frame: at baseline, at week 24

  17. Change from baseline in body weight after 12 weeks of treatment

    Time frame: at baseline, at week 12

  18. Change from baseline in body weight after 24 weeks of treatment

    Time frame: at baseline, at week 24

  19. 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

  20. 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

  21. Investigator's overall effectiveness evaluation after 12 weeks of treatment

    Time frame: at week 12

    • 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".

  22. Investigator's overall effectiveness evaluation after 24 weeks of treatment

    Time frame: at week 24

    • 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".

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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