Status:
COMPLETED
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Heart Failure
Eligibility:
All Genders
19+ years
Brief 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 se...
Eligibility Criteria
Inclusion
- 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®
Exclusion
Key Trial Info
Start Date :
July 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT05236673
Start Date
July 28 2022
End Date
April 30 2025
Last Update
May 16 2025
Active Locations (21)
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1
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea, 14068
2
Inje University Busan Paik Hospital
Busan, South Korea, 47392
3
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
4
Pusan National University Hospital
Busan, South Korea, 49241