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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-28

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who have started at first time on Jardiance®

JARDIANCE®

Intervention Type DRUG

JARDIANCE® film-coated tablets 10mg

Interventions

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JARDIANCE®

JARDIANCE® film-coated tablets 10mg

Intervention Type DRUG

Other Intervention Names

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empagliflozin

Eligibility Criteria

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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®

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No