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

Recruiting
19 years of age
Both
Phase N/A

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Overview

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

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 details

Heart Failure

NCT05236673

Boehringer Ingelheim

16 April 2024

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