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

Boehringer Ingelheim

Status: Completed

Conditions: Heart Failure

Treatments: Drug: JARDIANCE®

Study type: Observational

Funder types: Industry

Identifiers

NCT05236673

1245-0276

Details and patient eligibility

About

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.

Enrollment: 610 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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®

Trial design

610 participants in 1 patient group

Patients who have started at first time on Jardiance®

Treatment:

Drug: JARDIANCE®