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

Heart Failure Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236673
• Other study ID #: 1245-0276
• Status: Recruiting
• Start date: July 27, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• JARDIANCE®
JARDIANCE® film-coated tablets 10mg

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang-si, Gyeonggi-do
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Pusan National University Yangsan Hospital	Busan
Korea, Republic of	Kangwon National University Hospital	Chuncheon-si, Gangwon-do
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Dongguk University Medical Center	Goyang-si, Gyeonggi-do
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si, Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital)	Gwangju
Korea, Republic of	Jeonbuk National University Hospital	Jeonju-si, Jeollabuk-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	VHS Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital	Uijeongbu-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of hospitalization for heart failure (first and recurrent) after 12 weeks of treatment from baseline		at week 12
Secondary	Occurrence of hospitalization for heart failure (first and recurrent) after 24 weeks of treatment from baseline		at week 24
Secondary	Occurrence of cardiovascular death after 12 weeks of treatment		at week 12
Secondary	Occurrence of cardiovascular death after 24 weeks of treatment		at week 24
Secondary	Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatments		at baseline, at week 12
Secondary	Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatments		at baseline, at week 24
Secondary	Changes in ejection fraction (EF) (if available) at 12 weeks compared to baseline		at baseline, at week 12
Secondary	Changes in ejection fraction (EF) (if available) at 24 weeks compared to baseline		at baseline, at week 24
Secondary	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
Secondary	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
Secondary	Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment		at baseline, at week 12
Secondary	Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment		at baseline, at week 12
Secondary	Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment		at baseline, at week 24
Secondary	Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment		at baseline, at week 24
Secondary	Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 12 weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 24 weeks of treatment		at baseline, at week 24
Secondary	Change from baseline in body weight after 12 weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in body weight after 24 weeks of treatment		at baseline, at week 24
Secondary	Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 12 weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 24 weeks of treatment		at baseline, at week 24
Secondary	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
Secondary	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

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