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Completed
NCT05236673
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
Conditions: Heart Failure
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 676
Sponsor: Boehringer Ingelheim
Location: Hallym University Medical Center Anyang-si, Gyeonggi-do
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.
Eligibility Criteria
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®
Source: ClinicalTrials.gov (NCT05236673). StuddyBuddy aggregates publicly available trial information.