CompletedNot Applicable

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

South Korea676 participantsStarted 2022-07-28

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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®

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Adverse Events (AEs)

Timeframe: Up to 407 days.

Number of Patients With Unexpected Adverse Events

Timeframe: Up to 407 days.

Number of Patients With Unexpected Adverse Drug Reaction

Timeframe: Up to 407 days.

Number of Patients With Serious Adverse Events

Timeframe: Up to 407 days.

Number of Patients With Serious Adverse Drug Reaction

Timeframe: Up to 407 days.

Number of Patients With Drug-related Adverse Events

Timeframe: Up to 407 days.

Number of Patients With Non-serious Adverse Drug Reaction

Timeframe: Up to 407 days.

Trial details

NCT IDNCT05236673

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-30

Results submitted2026-04-29

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Patients With Adverse Events (AEs)

Timeframe: Up to 407 days.

Number of Patients With Unexpected Adverse Events

Timeframe: Up to 407 days.

Number of Patients With Unexpected Adverse Drug Reaction

Timeframe: Up to 407 days.

Number of Patients With Serious Adverse Events

Timeframe: Up to 407 days.

Number of Patients With Serious Adverse Drug Reaction

Timeframe: Up to 407 days.

Number of Patients With Drug-related Adverse Events

Timeframe: Up to 407 days.

Number of Patients With Non-serious Adverse Drug Reaction

Timeframe: Up to 407 days.